FDA Adverse Event Injury Summary report: N

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

MDR report key: 3861431 · Received June 10, 2014

Report

Report Number: 2183613-2014-00885
Event Type: Injury
Date Received: June 10, 2014
Date of Event: April 10, 2014
Report Date: April 10, 2014
Manufacturer: MEDTRONIC MILACA, INC.
Product Code: LWP
PMA / PMN Number: P820003
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EMERGENCY BUTTON ISSUE; DEVICE PASSED ALL INCOMING FUNCTIONAL. ANALYSIS CONFIRMED THE REPORTED LCD (LIQUID CRYSTAL DISPLAY) ISSUE; LCD DISPLAY BLEEDING. ANALYSIS ALSO FOUND THE UPPER CASE, TWO SIDE BAIL COVERS, RING COVER, AND LEAD FLEX COVER IS CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED AND THE RING IS BENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE DEVICE DID NOT ENTER "EMERGENCY" PACING MODE DESPITE BUTTON BEING PRESSED SEVERAL TIMES. IT WAS ALSO NOTED THE DISPLAY IS SLIGHTLY DEFECTIVE AT TOP NEAR "A+V" TEXT. 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
338016		PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	MEDTRONIC MILACA, INC.	5388X

Patients

Seq	Age	Sex	Outcome	Treatment
1