INTERSTIM II

MDR report key: 8621315 · Received May 17, 2019

Report

Report Number: 3004209178-2019-09844
Event Type: Injury
Date Received: May 17, 2019
Date of Event: April 29, 2019
Report Date: May 17, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: EZW
UDI-DI: 00613994913654
PMA / PMN Number: P970004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED FROM A FAMILY MEMBER OF A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. PATIENT'S DAUGHTER SAID THE PATIENT COULDN'T PEE; THEY WERE TRYING TO MAKE CHANGES TO THE DEVICE SO THEY COULD PEE AGAIN. DURING THE CALL, THE CALLER CONNECTED TO THE INS AND CHANGED THE PROGRAM FROM 1 TO 2 AND SET STIMULATION TO 1.8V. IT WAS NOTED THAT STIMULATION WAS OFF WHICH WAS WHY THE CALLER COULDN'T INCREASE STIMULATION. UPON TURNING THE INS BACK ON, THE PATIENT COULD FEEL STIMULATION. IT AS ALSO NOTED THAT THE PATIENT IS CURRENTLY ONLY PEEING DRIBBLES. AS A RESULT OF WHAT WAS REPORTED, THE CALLER WAS REDIRECTED TO THE HEALTHCARE PROVIDER (HCP) TO ADDRESS THE URINARY RETENTION. IT WAS DISCOVERED ON THE DATE OF THE INITIAL REPORT THAT THE INS WAS OFF; IT WAS UNKNOWN AS TO HOW THE IMPLANT GOT TURNED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
414710	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC PUERTO RICO OPERATIONS CO.	3058		00613994913654

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR		Other