FDA Adverse Event Injury Summary report: N

SETROX S 53

MDR report key: 1020475 · Received March 28, 2008

Report

Report Number: 1028232-2008-00330
Event Type: Injury
Date Received: March 28, 2008
Date of Event: October 23, 2007
Report Date: March 3, 2008
Manufacturer: BIOTRONIK GMBH AND CO.
Product Code: DTB
PMA / PMN Number: P950037
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE ANALYSIS WAS ABLE TO CONFIRM THAT THE LEAD BODY SHOWED VERY PRONOUNCED SIGNS OF ABRASION. THE POSITION AND CHARACTERISTICS OF THE ABRASIONS, AS WELL AS THE IMPRINTS OF THE HELIX ON THE SILICONE TUBE, SUGGEST A SIMULTANEOUS OCCURRENCE OF STRONG PRESSURE OF THE LEAD ONTO THE PACEMAKER HOUSING AND EXCESSIVE FRICTION OF THE LEAD AT THE PACEMAKER HOUSING. FRICTION OF THE LEAD AGAINST OTHER LEADS IN THE IMPLANTED STATE SHOULD ALSO BE CONSIDERED. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND, WHICH WOULD BE ABLE TO PROVIDE INFORMATION IN THE POSITIONS OF THE PARTS OF THE IMPLANTED SYSTEM IN THE BODY IN RELATION TO EACH OTHER, WERE NOT AVAILABLE FOR ANALYSIS. THE ANALYSIS OF THE DAMAGE AT THE LEAD DID NOT SHOW ANY INDICATIONS FOR MANUFACTURING ERRORS OR MATERIAL DEFECTS.

Description of Event or Problem · 1

AN INSULATION DEFECT OF THE LEAD WAS REPORTED. THE LEAD HAD BEEN IMPLANTED FOR 12 MONTHS. THE LEAD WAS EXPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SETROX S 53	PACER LEAD	DTB	BIOTRONIK GMBH AND CO.	350974

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization