FDA Adverse Event Injury Summary report: N

SPRINT QUATTRO SECURE

MDR report key: 1791741 · Received August 10, 2010

Report

Report Number: 2649622-2010-06959
Event Type: Injury
Date Received: August 10, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: LWS
PMA / PMN Number: P920015/S24
Removal / Correction Number: ASKU
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND UPON ANALYSIS. THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, FRACTURED (OVERSTRESS), AND CUT. SEVERAL CONDUCTORS WERE STRETCHED AND FRACTURED (OVERSTRESS). THE OUTER TUBING OVERLAY WAS MELTED AND BREACHED CUT. THE OUTER INSULATION WAS TORN AND BREACHED CUT. THE LEAD WAS STRETCHED. THE FULL LEAD IN SEGMENTS WAS RETURNED WITH TOO MUCH EXPLANT DAMAGE TO DETERMINE IF THERE WAS A FRACTURED SVC CABLE.

Description of Event or Problem · 1

IT WAS REPORTED THE DAILY LEAD IMPEDANCE ON THE SVC LEAD WAS >200 OHMS DUE TO A FRACTURED COIL. AFTER DFT TESTING CONFIRMED AN ACCEPTABLE DFT WITH ONLY THE HVB COIL, THE PHYSICIAN (ALONG WITH THE PATIENT) CHOOSE NOT TO DO ANY INTERVENTION AT THAT TIME. THE LEAD WAS MONITORED UNTIL THE TIME OF DEVICE REPLACEMENT. IT WAS FURTHER REPORTED THAT THERE WAS A LEAD FRACTURED AT THE SVC COIL. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPRINT QUATTRO SECURE	IMPLANTABLE TACHY LEAD	LWS	MEDTRONIC PUERTO RICO, INC.	6947	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Required Intervention	7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB\| 5076 IMPLANTABLE PACING LEAD