FDA Adverse Event Malfunction Summary report: N

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

MDR report key: 2951478 · Received February 9, 2013

Report

Report Number: 2183613-2013-00015
Event Type: Malfunction
Date Received: February 9, 2013
Date of Event: October 30, 2012
Report Date: November 5, 2012
Manufacturer: MEDTRONIC MILACA, INC.
Product Code: LWP
PMA / PMN Number: P820003/S72
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

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).

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE ATRIAL OUTPUT CONNECTOR LOCK WAS BROKEN OFF. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASE HALVES WERE BROKEN, BOTH BAIL COVERS AND RING COVER WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT AND ONE CASE SCREW WAS THE WRONG SIZE. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ATRIAL CONNECTOR ON THE EXTERNAL PULSE GENERATOR WAS BROKEN. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ATRIAL CONNECTOR ON THE EXTERNAL PULSE GENERATOR WAS BROKEN. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
56421		PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	MEDTRONIC MILACA, INC.	5388

Patients

Seq	Age	Sex	Outcome	Treatment
1