FDA Adverse Event Malfunction Summary report: N

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

MDR report key: 2953441 · Received February 9, 2013

Report

Report Number: 2182208-2013-00309
Event Type: Malfunction
Date Received: February 9, 2013
Report Date: November 14, 2012
Manufacturer: RICE CREEK MFG
Product Code: LWP
PMA / PMN Number: P820003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; HEART WIRE CONNECTOR POSITIVE LOCKING WHEEL IS BROKEN OFF. CONTAMINATION FOUND BETWEEN CASE HALVES. CABLE IS TWISTED APPROXIMATELY 47 INCHES FROM HEART WIRE CONNECTOR. CABLE CONTINUITY TESTS OK. NO INTERMITTENT CONNECTION FOUND WHEN CABLE IS BENT / MANIPULATED. CONNECTIONS WERE NOT SHORTING OUT BETWEEN THEMSELVES.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) CABLES WERE "BROKEN." OF NOTE, THE PLASTIC SCREW KNOB SHOWED "PHYSICAL BREAKAGE." THE HOSPITAL HAD RECENTLY REVISED THEIR CLEANING/STERILIZATION PROCESS AND NOTED THE CABLES WERE "BREAKING" FOLLOWING THE STERILIZATION PROCESS. THE CABLES WILL BE RETURNED. NO PATIENT INVOLVEMENT OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

THE CABLES WERE RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
56048		PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	RICE CREEK MFG	5433AL	0707

Patients

Seq	Age	Sex	Outcome	Treatment
1