FDA Adverse Event Malfunction Summary report: N

SELOX SR 53

MDR report key: 1861253 · Received October 1, 2010

Report

Report Number: 1028232-2010-01986
Event Type: Malfunction
Date Received: October 1, 2010
Date of Event: May 24, 2010
Report Date: September 1, 2010
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: DXY
PMA / PMN Number: P950037
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

OUS MDR - THE ANALYSIS OF THE SELOX AND KENTROX LEADS DETERMINED THAT THE INSULATION OF BOTH LEADS WERE FRAYED. THIS DAMAGE IS, WITH HIGH PROBABILITY, TO BE REGARDED AS THE CAUSE FOR THE CLINICAL COMPLAINT. THE OBSERVED DAMAGE MANIFESTATION REQUIRES EXCESSIVE MECHANICAL STRESS ON THE LEAD OVER A LONGER PERIOD OF TIME. THE POSITION AND CHARACTERISTICS OF THE FRAYING IN THE PROXIMAL REGION LEAD TO THE ASSUMPTION OF FRICTION BETWEEN THE SELOX AND A PARTNER LEAD. WHEREAS THE FRAYING IN THE DISTAL REGION LEADS TO THE ASSUMPTION OF EXCESSIVE MECHANICAL STRESS OF THE LEADS IN THE REGION OF THE VALVE PLANE. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND THAT COULD PROVIDE INFORMATION ON THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY WERE NOT AVAILABLE FOR ANALYSIS. THE DEFORMATION OF THE SHOCK COILS AND INNER CONDUCTOR HELIX IS PROBABLY DUE TO THE EXPLANTATION PROCEDURE.

Description of Event or Problem · 1

OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 5 YEARS, OVERSENSING WITH MULTIPLE SHOCK DELIVERIES WAS REPORTED. THERE WAS NO IMPLANT DATE PROVIDED. THE ENTIRE SYSTEM WAS EXPLANTED AND NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED. LUMAX 540 DR-T, (B)(4), MDR: 1028232-2010-01985. KENTROX SL-S 65/16 STEROID, (B)(4), MDR: 1028232-2010-01987.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SELOX SR 53	PACER LEAD	DXY	BIOTRONIK SE & CO. KG	343083

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization