FDA Adverse Event Malfunction Summary report: N

INTERSTIM II

MDR report key: 4871359 · Received June 26, 2015

Report

Report Number: 3004209178-2015-12319
Event Type: Malfunction
Date Received: June 26, 2015
Date of Event: June 4, 2015
Report Date: June 4, 2015
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P970004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-33, LOT# VA0421UM IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS NOT BEING ABLE TO ADJUST STIMULATION AND THE PATIENT PROGRAMMER DISPLAY SHOWED A ¿CALL YOUR DOCTOR¿ ICON. THE PATIENT SAW THE DOCTOR ICON, BUT DIDN¿T KNOW WHAT CODE. TODAY WITH THE CLINICIAN PROGRAMMER THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD LOST ITS PROGRAMMING AND THE PATIENT PROGRAMMER WAS NO LONGER BONDED WITH THE INS. THE MANUFACTURER REPRESENTATIVE WASN¿T SURE OF THE CLINICIAN PROGRAMMER SCREENS, BUT THEY RECEIVED SOME TYPE OF ERROR MESSAGE WHEN THEY FIRST INTERROGATED THE INS WITH THE CLINICIAN PROGRAMMER. ALL PROGRAMMING WAS GONE, SO THE MANUFACTURER REPRESENTATIVE REPROGRAMMED THE INS AND REBONDED THE PATIENT PROGRAMMER. THE PATIENT WAS FEELING STIMULATION FINE AGAIN. THE PATIENT HAD NOT HAD ANY ELECTROMAGNETIC INTERFERENCE (EMI) EXPOSURES. THE PATIENT ASSOCIATED THE LOSS OF PROGRAMMING WITH BEING PROGRAMMED 2 MONTHS AGO. IT WAS REVIEWED THAT IT WAS UNLIKELY SINCE THE LOSS OF PROGRAMMING OCCURRED RECENTLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
416142	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1	00065 YR