FDA Adverse Event Malfunction Summary report: N

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

MDR report key: 2865086 · Received December 10, 2012

Report

Report Number: 2183613-2012-02047
Event Type: Malfunction
Date Received: December 10, 2012
Date of Event: October 8, 2012
Report Date: December 4, 2012
Manufacturer: MEDTRONIC MILACA, INC.
Product Code: LWP
PMA / PMN Number: P820003/0S72
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: HEALTH 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 COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN AND CONTAMINATED, THE BATTERY RELEASE, LEAD FLEX COVER AND BATTERY DRAWER WERE CONTAMINATED, THE RING COVER WAS CONTAMINATED, THE TWO SIDE BAIL COVERS WERE BROKEN AND CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, AND THE KEYBOARD PAD WAS COSMETICALLY DAMAGED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE READINGS OF THE DEVICE WERE INACCURATE ACCORDING TO STAFF. THE DEVICE WAS RETURNED FOR CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THE READINGS OF THE DEVICE WERE INACCURATE ACCORDING TO STAFF. THE DEVICE WAS RETURNED FOR CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1