FDA Adverse Event Malfunction Summary report: N

ENDOTAK SQ

MDR report key: 3050040 · Received April 10, 2013

Report

Report Number: 2124215-2013-04647
Event Type: Malfunction
Date Received: April 10, 2013
Date of Event: February 14, 2013
Report Date: February 15, 2013
Manufacturer: CPI - DEL CARIBE
Product Code: DTB
PMA / PMN Number: P910077
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 PATIENT'S HOME MONITORING SYSTEM DETECTED A LOW, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD, SUBCUTANEOUS SHOCKING LEAD, AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. THE READING GENERATED WAS ZERO AND COINCIDED WITH WHEN THE PATIENT WAS AT PHYSICAL THERAPY. IT WAS THOUGHT THAT LIKELY THE READING WAS DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) AS BOTH PREVIOUS AND SUBSEQUENT MEASUREMENTS WERE NORMAL, AND THE READING COULD NOT BE REPRODUCED AT THE TIME OF THE EVALUATION. REVIEW OF THE STORED EVENTS SHOW THAT LATE LAST SUMMER THERE WAS SOME OVERSENSING OF NOISE ON THE RV LEAD THAT RESULTED IN SOME INAPPROPRIATE NONSUSTAINED VENTRICULAR TACHYCARDIA DETECTIONS. NO THERAPY WAS DELIVERED FOR THESE AND NO PACING INHIBITION GREATER THAN TWO SECONDS WAS NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE PLAN WAS TO MONITOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
153191	ENDOTAK SQ	IMPLANTABLE LEAD	DTB	CPI - DEL CARIBE	0085

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR			4047\| 0184\| 4592\| N119\| 4591\| 4135\| 4555\| 0085