FDA Adverse Event Malfunction Summary report: N

SELOX ST 60

MDR report key: 3984506 · Received August 6, 2014

Report

Report Number: 1028232-2014-002746
Event Type: Malfunction
Date Received: August 6, 2014
Date of Event: May 25, 2014
Report Date: July 28, 2014
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVN
PMA / PMN Number: P950037
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT, THE LEAD WAS FOUND DISSECTED. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED. THE LEAD TIP INCLUDING THE TINES WEREN'T RETURNED FOR ANALYSIS. IT IS REASONABLE TO ASSUME, THAT THE DISSECTION OF THE LEAD ORIGINATED FROM THE EXPLANTATION PROCEDURE. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE OUTER CONDUCTOR COIL. BASED ON THE SYMPTOMS, IT IS REASONABLE TO ASSUME THAT THESE DAMAGES RESULTED FROM THE EXPLANTATION PROCEDURE. WITH REGARD TO THE PACING ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS OF THE LEAD DID NOT SHOW ANY DEVIATIONS. THE DC RESISTANCES OF THE CONDUCTOR FRAGMENTS WERE INVESTIGATED. NO PECULIARITIES WERE FOUND. IN SUMMARY, CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE OUTER COIL WERE OBSERVED, WHICH RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

Description of Event or Problem · 1

OUS MDR - IT WAS REPORTED THAT 11 MONTHS AFTER THE IMPLANTATION THE VENTRICULAR THRESHOLD WAS HIGH AND THERE WAS NO STIMULATION. DURING THE REVISION, WHILE PULLING THE LEAD, THE DISTAL PART OF THIS LEAD DETACHED AND REMAINED IN THE PATIENT. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED, BUT IT IS UNCLEAR IF ALL OF IT WAS RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
459508	SELOX ST 60	PACER LEAD	NVN	BIOTRONIK SE & CO. KG	346367

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization