FDA Adverse Event Malfunction Summary report: N

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

MDR report key: 3860052 · Received June 10, 2014

Report

Report Number: 2183613-2014-00805
Event Type: Malfunction
Date Received: June 10, 2014
Date of Event: April 29, 2014
Report Date: April 29, 2014
Manufacturer: MEDTRONIC MILACA, INC.
Product Code: LWP
PMA / PMN Number: P820003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: INITIAL ANALYSIS CONFIRMED THE REPORTED EVENT, THE DISPLAY LENS WAS CRACKED AND ALL FOUR CONTROL KNOBS WERE MISSING. IT WAS ALSO NOTED THAT THE LOWER CASE WAS BROKEN, THE RING COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD WAS DAMAGED AND OUT OF MECHANICAL SPECIFICATION AND THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. VISUAL INSPECTION REVEALED NO ANOMALIES. BENCH ANALYSIS REVEALED AN ERROR CODE. AFTER AN INTEGRATED CIRCUIT COMPONENT WAS REPLACED TYPICAL OPERATION WAS OBSERVED. CONCLUSION: CONFIRMED THE REPORTED FAILURES SEEN DURING SERVICE AND REPAIR OF THE DEVICE CAUSED BY A DEFECTIVE INTEGRATED CIRCUIT COMPONENT.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A BROKEN SCREEN AND MISSING KNOBS. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
340413		PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	MEDTRONIC MILACA, INC.	5388

Patients

Seq	Age	Sex	Outcome	Treatment
1