FDA Adverse Event Summary report: N

PACEMAKER

MDR report key: 21301 · Received December 30, 1994

Report

Report Number: 21301
Date Received: December 30, 1994
Report Date: December 30, 1994
Manufacturer: CARDIAC PACEMAKER INC.
Product Code: DSZ
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

BATTERY PROBLEM IN NEW PACEMAKER RESULTING IN RETURN TO SURGERY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PACEMAKER		DSZ	CARDIAC PACEMAKER INC.	940

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Invalid Data