INTERSTIM II

MDR report key: 4521597 · Received February 17, 2015

Report

Report Number: 3004209178-2015-03147
Event Type: Malfunction
Date Received: February 17, 2015
Date of Event: January 23, 2015
Report Date: January 23, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
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).

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCT: PRODUCT ID: 3093-28, LOT# V001988, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE IMPEDANCES RESOLVED AFTER THE LEAD WAS REPLACED. THE ORIGINAL LEAD WAS DAMAGED. THE LEAD LOOKED LIKE IT WAS COMING APART. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT¿S STIMULATOR WAS BEING REPLACED DUE TO NORMAL BATTERY DEPLETION. PRIOR TO REPLACEMENT, THE IMPEDANCES WERE WITHIN NORMAL LIMITS. ALL BILATERAL PAIRS SHOWED GREATER THAN 4,000 OHMS IMPEDANCE DURING THE REPLACEMENT. THE LEAD WAS REPLACED. THE HEALTHCARE PROVIDER HAD SOME TROUBLE INSERTING THE LEAD AND HAD TO LOOSEN THE SETSCREW TO FULLY INSERT. IMPEDANCES WERE STILL GREATER THAN 4,000 OHMS, EVEN AFTER INCREASING THE VOLTAGE AND PULSE WIDTH. TWO UNIPOLAR AND ONE BIPOLAR PAIR HAD NORMAL READINGS. THE LEAD WAS ABLE TO BE PULLED OUT OF THE STIMULATOR. THE LEAD COULD BE PULLED OUT EVEN AFTER THE TORQUE WRENCH CLICKED. NO OUTCOME WAS 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
115081	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC PUERTO RICO OPERATIONS CO.	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1	00062 YR