FDA Adverse Event Injury Summary report: N

AMS PRODUCT GROUP, INC.)

MDR report key: 7620 · Received February 3, 1994

Report

Report Number: 7620
Event Type: Injury
Date Received: February 3, 1994
Date of Event: May 4, 1993
Report Date: July 23, 1993
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC. (DIVISION OF PFIZER HOSPITAL
Product Code: FAG
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

AN 80 YEAR OLD MALE PATIENT HAD THE ORIGINAL AUS IMPLANTED 17 YEARS AGO AT THE CLINIC. THE PUMP MALFUNCTIONED, REQUIRING REPLACEMENT. FOR THE PAST FOUR OR FIVE YEARS HD HAD MINIMAL PROBLEMS WITH THE DEVICE. WHEN STRAINING, COUGHING AND PERFORMING VALSALVA'S MANEUVER IT WOULD CAUSE URINARY LEAKS. AS A PROTECTION HE HAS BEEN WEARING DIAPERS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, MECHANICAL PROBLEM, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AMS PRODUCT GROUP, INC.) Implant	ARTIFICIAL URETHRAL SPHINCTER	FAG	AMERICAN MEDICAL SYSTEMS, INC. (DIVISION OF PFIZER HOSPITAL	800	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Required Intervention