INTERSTIM

MDR report key: 2860915 · Received December 6, 2012

Report

Report Number: 9614453-2012-00236
Event Type: Injury
Date Received: December 6, 2012
Date of Event: November 13, 2012
Report Date: November 13, 2012
Manufacturer: IPG MFG SWITZERLAND
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3889-28, SERIAL# UNKNOWN, IMPLANTED: 2005-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE LEAD BROKE DURING AN EXPLANT PROCEDURE. THE EXPLANT PROCEDURE WAS COMPLETED BECAUSE THE PATIENT NEVER REPORTED A CLINICAL RESPONSE TO SACRAL NEUROMODULATION. FURTHER SURGICAL INTERVENTION WAS REQUIRED. IT WAS STATED THAT THE PHYSICIAN HAD TO "DISSECT AND GO DEEPER" SO THAT THEY COULD REMOVE THE TINES AND THE DISTAL PART OF THE LEAD. IT WAS UNCLEAR IF THE ENTIRE SYSTEM WAS REMOVED, OR JUST THE LEAD. THE PATIENT'S STATUS WAS LISTED AS NO INJURY AND NO ADVERSE EVENT. ABOUT THREE WEEKS LATER, IT WAS FURTHER REPORTED THAT THE PATIENT FELT "OK." NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTERSTIM	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	IPG MFG SWITZERLAND	302336

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention