FDA Adverse Event Malfunction Summary report: N

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

MDR report key: 2951640 · Received February 9, 2013

Report

Report Number: 2183613-2013-00060
Event Type: Malfunction
Date Received: February 9, 2013
Date of Event: November 1, 2012
Report Date: February 25, 2013
Manufacturer: MEDTRONIC MILACA, INC.
Product Code: LWP
PMA / PMN Number: P820003/S070
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY EVALUATION SUMMARY (B)(4) : THE GENERATOR WAS RETURNED, AND ANALYSIS CONFIRMED THE CUSTOMER COMMENTS THAT THE PLASTIC COVER WAS MISSING FROM ITS KEYBOARD AND THE "ON" BUTTON OF THE KEYPAD WAS OUT OF SPECIFICATION (IT WAS COLLAPSED). ANALYSIS ALSO FOUND THAT THE INTERCONNECT FLEX WAS OUT OF SPECIFICATION, THAT THE HEART LEAD FLEX WAS CONTAMINATED AND THAT THE UPPER AND LOWER CASES, ONE SIDE BAIL COVER AND THE RING COVER WERE BROKEN. (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)(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 THE POWER BUTTON IS INTERMITTENT. THE PLASTIC COVER IS MISSING. THE DEVICE WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THE POWER BUTTON IS INTERMITTENT. THE PLASTIC COVER IS MISSING. THE DEVICE WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
55745		PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	MEDTRONIC MILACA, INC.	5348

Patients

Seq	Age	Sex	Outcome	Treatment
1