FDA Adverse Event Malfunction Summary report: N

INTERSTIM II

MDR report key: 4708225 · Received April 20, 2015

Report

Report Number: 3004209178-2015-07567
Event Type: Malfunction
Date Received: April 20, 2015
Report Date: March 30, 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: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID: NEU_PTM_PROG, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V840219, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT HAD NO STIMULATION. INCREASING TO 2.6 V RESOLVED THE ISSUE. BATTERY LONGEVITY WAS A CONCERN, BUT THE PATIENT WAS ABLE TO SYNC AND CONFIRM THE BATTERY WAS NOT AT END OF SERVICE. THE PATIENT DID NOT THINK THEIR DEVICE WAS WORKING. THEY HAD BEEN ABLE TO MAKE IT TO THE BATHROOM, BUT COULD NO LONGER MAKE IT IN TIME. THE PATIENT WAS LEAKING THROUGH A DIAPER AND TWO PADS. THERAPY WAS SOMETIMES BETTER AND SOMETIMES WORSE. THEIR SYMPTOMS WERE WORSE WHEN THEY LAY DOWN. THE PATIENT HAD A SINGLE EPISODE OF SHOCKING THAT WAS NOT RELATED TO BODY POSITION. LAST SPRING, THE PATIENT THOUGHT THEY WERE HAVING A MINI-STROKE, BUT IT WAS ACTUALLY DUE TO A NERVE BY THEIR EYE. THE NERVE CAUSED DOUBLE VISION. TWO WEEKS AFTER THE CALL, THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. AN APPOINTMENT DATE OF (B)(6) 2015 WAS NOTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
260965	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1	00069 YR