FDA Adverse Event Malfunction Summary report: N

INTERSTIM II

MDR report key: 4799211 · Received May 27, 2015

Report

Report Number: 3004209178-2015-09748
Event Type: Malfunction
Date Received: May 27, 2015
Report Date: May 4, 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: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V802404, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V802404, IMPLANTED: (B)(6) 2011, 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 SHOCKING OR JOLTING SENSATION. THIS OCCURRED INTERMITTENTLY SINCE (B)(6) 2015, BUT TODAY IT WAS PRETTY CONSTANT. USUALLY WHEN IT HAPPENED IT WAS JUST ONCE AND THEN IT SUBSIDED AFTER ABOUT AN HOUR. TODAY THE PATIENT RECEIVED SEVERAL IN A ROW AND PRETTY FREQUENTLY. THE PATIENT HAD NOT TURNED STIMULATION OFF TO DETERMINE IF THAT MADE A DIFFERENCE AS THE OCCURRENCE WAS TYPICALLY INTERMITTENT AND THERE WAS SOMETIMES A MONTH BETWEEN INCIDENTS. THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPROGRAMMED ABOUT A MONTH AGO AND WAS TOLD THAT ONE OF THE CONTACTS WAS BROKEN OR SOMETHING LIKE THAT. THE PATIENT HAD A FALL, BUT NOTHING RECENTLY. NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
343075	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1