FDA Adverse Event Malfunction Summary report: N

LINOX TD 65/18

MDR report key: 2771484 · Received September 28, 2012

Report

Report Number: 1028232-2012-02427
Event Type: Malfunction
Date Received: September 28, 2012
Date of Event: September 12, 2012
Report Date: September 17, 2012
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: LWS
PMA / PMN Number: P980023
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS OF THE LEAD DEMONSTRATED MULTIPLE SIGNS OF ABRASION AND A RUBBED THROUGH INSULATION. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED OVERSENSING ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN THIS SECTION A CONDUCTOR FRACTURE WAS NOTED. COAGULATED BLOOD IN THE LUMEN OF THE LEAD WAS FOUND IN THIS AREA. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF MECHANICAL INTERACTION BETWEEN THE LEAD BODY AND THE ICD CAN. THE DEFORMATION OF THE RV SHOCK COIL OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSES DID NOT REVEALED ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

Description of Event or Problem · 1

THIS LEAD WAS CONNECTED TO A NEW DEVICE AND DFT TESTING WAS PERFORMED. THERE WAS ARCING BETWEEN THIS LEAD AND THE DEVICE COULD NOT BE INTERROGATED. WHEN THIS LEAD WAS CONNECTED TO ANOTHER ICD, THE SHOCK IMPEDANCE WAS GREATER THAN 150 OHMS. UPON EXPLANT OF THIS LEAD, THE PHYSICIAN NOTED A POSSIBLE INSULATION BREAK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LINOX TD 65/18	ICD LEAD	LWS	BIOTRONIK SE & CO. KG	351338

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Hospitalization