INTERSTIM

MDR report key: 2896848 · Received January 4, 2013

Report

Report Number: 9614453-2013-00007
Event Type: Injury
Date Received: January 4, 2013
Report Date: December 12, 2012
Manufacturer: IPG MFG SWITZERLAND
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3889, TYPE LEAD PRODUCT ID 3095, PRODUCT TYPE EXTENSION.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THE THERAPY WAS STILL NOT EFFECTIVE. IT WAS STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SUSPECTED OF A MALFUNCTION BECAUSE THE THERAPY WAS EFFECTIVE DURING THE TEST PERIOD AND THE PATIENT HAD A LACK OF EFFICACY WHEN THE INS WAS IMPLANTED. THERE WERE NO CONNECTION ISSUES REPORTED REGARDING THE INS. IT WAS NOTED THE PROBLEM REMAINED WITH THE REPLACEMENT INS. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) AFTER A SUCCESSFUL TRIAL PERIOD. WHEN IMPLANTED, THE PATIENT HAD A "TOTAL LOSS OF EFFICACY." NO THERAPEUTIC EFFECT COULD BE ACHIEVED. AFTER SEVERAL REPROGRAMMING ATTEMPTS, THERAPEUTIC EFFECT COULD STILL NOT BE ACHIEVED. THE INS WAS LATER REPLACED BECAUSE THE PATIENT EXPERIENCED PAIN AT THE IMPLANT SITE. THE PATIENT'S STATUS WAS LISTED AS NO INJURY AND NO ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
4676	INTERSTIM	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	IPG MFG SWITZERLAND	3023

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention