INTERSTIM II

MDR report key: 5192793 · Received October 30, 2015

Report

Report Number: 3004209178-2015-21949
Event Type: Injury
Date Received: October 30, 2015
Report Date: October 9, 2015
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCT: PRODUCT ID 3093-33, LOT # V833270, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

A PATIENT IMPLANTED FOR URINARY DYSFUNCTION AND GASTROINTESTINAL/PELVIC FLOOR REPORTED A LOSS OF THERAPY IN (B)(6) 2015. IT DID NOT SEEM TO BE CONTROLLING HER BLADDER ANYMORE FOR THE LAST COUPLE OF DAYS. THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA. A LOW BATTERY ICON WAS SEEN ON THE PATIENT PROGRAMMER, BUT THE PATIENT CONFIRMED THAT STIMULATION WAS ON. THE PATIENT NEEDED THE DEVICE REPLACED, HAD SEEN A DOCTOR, AND HAD SCHEDULED AN APPOINTMENT FOR SURGERY TO REPLACE THE DEVICE BATTERY. THE ISSUES HAD NOT BEEN RESOLVED YET. THE BATTERY REPLACEMENT CAME SOONER THAN INDICATED AT THE TIME OF IMPLANT. NO POTENTIAL EVENT CAUSE WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION FROM THE CONSUMER REPORTED THAT THERE WAS NO CHANGE IN ACTIVITY; SHE THOUGHT THE LIFE SPAN OF THE BATTERY LED TO THE UNEXPECTED BATTERY DISCHARGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
721082	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention