FDA Adverse Event Malfunction Summary report: N

N/I

MDR report key: 3590 · Received December 29, 1992

Report

Report Number: 3590
Event Type: Malfunction
Date Received: December 29, 1992
Date of Event: September 10, 1992
Report Date: September 17, 1992
Manufacturer: SIEMENS PACE SETTER SYSTEMS, INC.
Product Code: DSZ
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

IMPENDING PACEMAKER BATTERY FAILURE. ELECTIVE REPLACEMENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	N/I Implant	PACEMAKER	DSZ	SIEMENS PACE SETTER SYSTEMS, INC.	225-6	N/I

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other