FDA Adverse Event Injury Summary report: N

INTERSTIM II

MDR report key: 2772527 · Received October 4, 2012

Report

Report Number: 3004209178-2012-08886
Event Type: Injury
Date Received: October 4, 2012
Report Date: September 10, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID, 3889-28 LOT# V251861, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION RECENTLY THAT TURNED INTO A YEAST INFECTION. PATIENT WAS GOING TO HAVE HER DOCTOR CHECK ON HER VAGINAL MESH AS IT MAY HAVE MOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THE "BAD" UTI THE PATIENT HAD "IN (B)(6) 2012" HAD FOUND "2 TYPES" OF BACTERIA IN THE URINE. NO ADDITIONAL INFORMATION WAS REPORTED REGARDING THE EVENT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S URINARY TRACT INFECTION ONSET/DIAGNOSIS WAS (B)(6) 2012. IT WAS NOTED THERE WAS NO DEVICE PROBLEM. ADDITIONAL INFORMATION RECEIVED 6 DAYS LATER REPORTED, THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY BUT SHE HAD NOT SOUGHT FURTHER HELP. IT WAS NOTED THE PATIENT "NEEDED TO GET A CYSTOURETHROGRAM AFTER HER MESH WAS FIXED AND THEN THE DOCTOR WOULD GET HER DEVICE WORKING CORRECTLY."

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other