INTERSTIM II

MDR report key: 8346525 · Received February 17, 2019

Report

Report Number: 3004209178-2019-03374
Event Type: Malfunction
Date Received: February 17, 2019
Date of Event: January 29, 2019
Report Date: February 17, 2019
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P080025
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

PMA: P080025. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED A POOR COMMUNICATION SCREEN WAS SEEN ON THE PROGRAMMER, PATIENT REPORTED POOR COMMUNICATION BETWEEN THE IMPLANT AND THE PROGRAMMER, IT WOULD NOT SYNC SINCE ABOUT TUESDAY OR WEDNESDAY OF LAST WEEK. THE PATIENT STATES SHE IS HAVING A STRESS TEST DONE NEXT AND NEEDS TO BE ABLE TO CONNECT THE PROGRAMMER WITH THE IMPLANT. TROUBLESHOOTING INCLUDED: PATIENT HAD ALREADY TRIED NEW PROGRAMMER BATTERIES AND CONFIRMED THE ANTENNA WAS SECURE; THIS DID NOT RESOLVE THE ISSUE. WHEN ASKED IF THE PATIENT WAS GETTING ANY SYMPTOM RELIEF THE PATIENT ANSWERED THAT SHE DOESN¿T FEEL ANY STIMULATION, AND THAT SHE NOTICED THIS AROUND THE SAME TIME SHE WASN¿T ABLE TO SYNC. PATIENT WAS NOT GETTING SYMPTOM RELIEF. DUE TO THE AGE OF THE BATTERY THE PATIENT WAS ADVISED TO HAVE THE BATTERY CHECKED BY THEIR DOCTOR. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
139614	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR