FDA Adverse Event Malfunction Summary report: N

INTERSTIM II

MDR report key: 3241371 · Received July 22, 2013

Report

Report Number: 3004209178-2013-12120
Event Type: Malfunction
Date Received: July 22, 2013
Date of Event: July 1, 2013
Report Date: July 1, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P970004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

Additional Manufacturer Narrative · 1

ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (B)(4) FOUND NO ANOMALIES. THE RETURNED INS WAS CONNECTED TO A KNOWN GOOD LEAD. THE INS AND ELECTRODES OF THE LEAD WERE PLACED IN 0.9% SALINE SOLUTION. IMPEDANCES WERE MEASURE WITH A CLINICIAN PROGRAMMER. THERE WAS GOOD IMPEDANCE ON EVERY ELECTRODE PAIR. THE PMA/510(K) # WAS PREVIOUSLY REPORTED AS P840001. ADDITIONAL REVIEW INDICATES THE CORRECT PMA/510(K) # IS P970004.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS AN IMPEDANCE ISSUE. IMPEDANCES WERE CHECKED AND SEVERAL ERRORS OCCURRED. A ??? ERROR WAS SEEN. IT WAS NOTED THAT ALL ELECTRODES WERE AN ISSUE EXCEPT THE CASE +. THIS OCCURRED DURING THE PROCEDURE. THE LEAD WAS CLEANED AND TRIED 5 ADDITIONAL TIMES WITHOUT SUCCESS. BATTERY WAS REPLACED WITH ANOTHER ONE AND IT WORKED FINE. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
340857	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1