FDA Adverse Event Malfunction Summary report: N

INTERSTIM II

MDR report key: 2852827 · Received November 30, 2012

Report

Report Number: 3004209178-2012-10981
Event Type: Malfunction
Date Received: November 30, 2012
Report Date: November 4, 2012
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: NM, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3889-28, LOT# V915103, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT# V915103, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON AND OFF, THE PATIENT FELT RANDOM PULSES ON THE RIGHT SIDE 'IN THE FRONT AREA' THROUGHOUT THE DAY. THE REPORTER STATED THAT THE PATIENT THOUGHT SHE HAD A CELL PHONE VIBRATING IN HER POCKET EVERY FIVE MINUTES. IT WAS REPORTED THAT THE PATIENT TURNED OFF HER DEVICE LAST NIGHT AND SHE STILL FELT THE STIMULATION. IT WAS NOTED THAT THE PATIENT HAD CALLED HER PHYSICIAN. THE REPORTER STATED THAT THE PATIENT HAD NOT HAD ANY PRIOR ISSUES WITH THE DEVICE AND IT WAS WORKING WELL. IT WAS NOTED THAT THE PATIENT STATED THAT THE STIMULATION WAS NOT PAINFUL, ONLY 'ANNOYING.' ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MFR REPORT # 3004209178-2012-10980 IT WAS UNCLEAR WHICH DEVICE WAS THE CAUSE OF THE EVENT.

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