What are FDA adverse event reports for Charger, Pacemaker?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Charger, Pacemaker, there are 626 total reports including 22 death reports and 1 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe — widely used devices naturally generate more reports.

How should I interpret MAUDE data for Charger, Pacemaker?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance — it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data Public-data reference. official source

Charger, Pacemaker

Name: Charger, Pacemaker — FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Reviewed byPlainhospital Editorial, Hospital Quality Editorial Team · June 4, 2026

Open-data reference.

PlainHospital home → About this data

FDA MAUDE adverse event data · 1997–2002

What the Data Shows About Charger, Pacemaker

The FDA MAUDE database aggregates 626 adverse-event reports for Charger, Pacemaker spanning the period from 1997 through 2002. Of these, 22 are classified as death reports, 1 as injury reports, and 602 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 4 distinct event types and 5 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. Reports are associated with 6 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 6 years of MAUDE data, with the peak single-year volume reaching 392 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 5 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on 2026-05-15. This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

626

Total Reports

Death Reports

Injury Reports

602

Malfunctions

Event Types

Malfunction 602 (96.2%)

Death 22 (3.5%)

1 (0.2%)

Injury 1 (0.2%)

Patient Outcomes

Other 598 (95.2%)

Death 25 (4.0%)

3 (0.5%)

O 1 (0.2%)

Life Threatening 1 (0.2%)

Yearly Trend

1997: 3

1998: 21

1999: 208

2000: 392

2001: 1

2002: 1

Top Manufacturers

ZOLL MEDICAL CORP. 459

ZOLL MEDICAL CORPORATION 108

ZOLL MEDICAL CORP 56

ZOLL 1

ZOLL MEDICAL CPRPORATION 1

Event Locations

618 (98.7%)

HOSPITAL 5 (0.8%)

IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.2%)

NOT APPLICABLE 1 (0.2%)

OTHER 1 (0.2%)

Compare ZOLL MEDICAL CORP. vs ZOLL MEDICAL CORPORATION →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.

Read our methodology — how this data is sourced, computed, and verified.