FDA Adverse Event Malfunction Summary report: N

YP 60/15 BP

MDR report key: 1062202 · Received June 13, 2008

Report

Report Number: 1028232-2008-00632
Event Type: Malfunction
Date Received: June 13, 2008
Date of Event: February 12, 2008
Report Date: May 14, 2008
Manufacturer: BIOTRONIK GMBH AND CO.
Product Code: DTB
PMA / PMN Number: K993139
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

OUS MDR. THE X-RAY EXAMINATION OF THE LEAD SHOWED A BROKEN ELECTRICAL LINE (OUTER CONDUCTOR HELIX) IN THE AREA 2.3 CM DISTAL OF THE CONNECTOR PLUG PIN. THE ANALYSIS CHECKED THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD. THE ANALYSIS SHOWED DAMAGE TO THE OUTER INSULATION BY FRAYING IN A SPATIALLY LIMITED AREA JUST DISTAL OF THE CONNECTOR PLUG PIN. THE ELECTRICAL CONDUCTOR (OUTER CONDUCTOR HELIX) WAS BROKEN AT THIS SITE. FURTHERMORE, ADDITIONAL INSULATION DAMAGE AND DEFORMATIONS OF THE OUTER CONDUCTOR HELIX WERE DETECTED PROXIMAL OF THE LIGATURE. WITH HIGH PROBABILITY, THIS DAMAGE MANIFESTATION IS THE CONSEQUENCE OF HIGH LOCAL MECHANICAL STRESS ON THE LEAD IN THE IMPLANTED STATE. THE AVAILABLE X-RAY IMAGES INDICATE ESPECIALLY EXCESSIVE KINKING OF THE LEAD BODY DIRECTLY BEHIND THE IS-1 CONNECTOR PLUG. THE CHARACTERISTICS OF THE INSULATION DAMAGE PROXIMAL OF THE LIGATURE SUGGEST PRESSURE AND FRICTION AT THE HOUSING OF THE GENERATOR OR AT OTHER LEADS AS FRICTION PARTNERS.

Description of Event or Problem · 1

OUS MDR. AN INSULATION DEFECT WAS REPORTED AFTER AN IMPLANTATION PERIOD OF ABOUT 45 MONTHS. THE X-RAY SHOWED A KINK IN THE LEAD RIGHT BEHIND THE CONNECTOR PLUG. WHEN THE DEVICE WAS REMOVED, IT COULD BE SEEN THAT THE INSULATION WAS COMPLETELY SEVERED BEHIND THE IS-1 CONNECTOR PLUG. THE LEAD WAS EXPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	YP 60/15 BP	PACER LEAD	DTB	BIOTRONIK GMBH AND CO.	124857

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization