FDA Adverse Event Injury Summary report: N

ENERGEN

MDR report key: 2924889 · Received January 22, 2013

Report

Report Number: 2124215-2013-01475
Event Type: Injury
Date Received: January 22, 2013
Date of Event: November 12, 2012
Report Date: November 28, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED HIGH, OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. THE SYSTEM ALSO DISPLAYED NOISE THAT WAS OVERSENSED AND LEAD TO STORED NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE TO ASSES THE INTEGRITY OF THE SYSTEM. THE PHYSICIAN DID A TUG TEST AND NO MOVEMENT WAS SEEN AND THE TERMINAL PIN WAS NOTED TO BE PAST THE CONNECTOR BLOCK. THE LEAD CONTINUED TO DISPLAY PACING IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE. AT THAT TIME, IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS DISPLAYING PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS WHEN PROGRAMMED LV TIP TO RV COIL. THE RV IS-1 AND THE LV LEAD WERE REMOVED FROM THE HEADER AND THEN TESTED THROUGH THE PACING SYSTEMS ANALYZER (PSA) AND THEN RECONNECTED TO THE DEVICE WITH RESOLUTION OF THE CLINICAL OBSERVATIONS. THE SYSTEM REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
29069	ENERGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	N141

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Hospitalization\| L\| R	VEDR01\| 4555\| 4076\| 4074\| 0185\| N141