FDA Adverse Event Malfunction Summary report: N

PROTECTA XT DR

MDR report key: 2954394 · Received February 11, 2013

Report

Report Number: 3004209178-2013-02430
Event Type: Malfunction
Date Received: February 11, 2013
Date of Event: November 13, 2012
Report Date: November 15, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LWS
PMA / PMN Number: P980016
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2006. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT THERE WAS ALSO INHIBITION OF PACING DUE TO A LOOSE SETSCREW ON THE DEVICE HEADER. THE PATIENT WAS TAKEN TO THE CATH LAB WHILE BEING EXTERNALLY PACED TO FIX THE SET SCREW. THE DEVICE REMAINS IN USE AND THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING CHANGE OUT, IT WAS NOTED THE HIGH VOLTAGE "B" OF THE LEAD WAS NICKED AND REPAIRED WITH MEDICAL ADHESIVE. NOW THERE WAS OVERSENSING AND NOISE ON THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD RESULTING FROM LOOSE CONNECTION IN THE HEADER OF THE DEVICE. BOTH THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
58067	PROTECTA XT DR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	D314DRG

Patients

Seq	Age	Sex	Outcome	Treatment
1	00075 YR		Hospitalization\| R	6947 IMPLANTABLE TACHY LEAD