PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Report

Report Number: 2183613-2013-00673
Event Type: Malfunction
Date Received: June 7, 2013
Date of Event: April 19, 2013
Report Date: April 19, 2013
Manufacturer: MEDTRONIC MILACA, INC.
Product Code: LWP
PMA / PMN Number: P820003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE GENERATOR'S SENSE AND PACE PORTS WERE LOOSE. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN, ONE BAIL COVER WAS BROKEN AND ONE MISSING AND THAT THE KEYBOARD WAS SCRATCHED. (B)(4).

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)(6). (B)(4).

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 THE EXTERNAL PULSE GENERATOR'S SENSE AND PACE PORTS WERE LOOSE, AND WERE INTERMITTENTLY "FLYING." THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S SENSE AND PACE PORTS WERE LOOSE, AND WERE INTERMITTENTLY "FLYING." THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
252722		PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	MEDTRONIC MILACA, INC.	5388

Patients

Seq	Age	Sex	Outcome	Treatment
1