KENTROX RV-S 65 STEROID

MDR report key: 2903942 · Received November 29, 2012

Report

Report Number: 1028232-2012-02949
Event Type: Malfunction
Date Received: November 29, 2012
Date of Event: September 6, 2012
Report Date: November 12, 2012
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVY
PMA / PMN Number: P980023
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

OUS MDR.

Additional Manufacturer Narrative · 1

(B)(6) 2013 - CORRECTED THE EVENT DATE. THE KENTROX LEAD WAS CAPPED IN THE RETURNED STATE. THE ANALYSIS OF THE LEAD FRAGMENTS SHOWED A CONDUCTOR FRACTURE OF THE ROPE CONDUCTOR TO THE RV SHOCK COIL IN THE DF-1 CONNECTOR. THIS DEFECT MANIFESTATION IS PROBABLY A RESULT OF STRONG KINKING AND PRESSURE STRESSES IN THE AREA OF THE DF-1 CONNECTOR. OTHER DAMAGE AT THE KENTROX LEAD IS PROBABLY DUE TO THE EXPLANTATION. THE CAUSE FOR THE COMPLAINT ABOUT THE KENTROX LEAD COULD NOT BE IDENTIFIED. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND, WHICH COULD PROVIDE INFORMATION ON THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY, WERE NOT AVAILABLE FOR ANALYSIS. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS FOR EITHER THE KENTROX OR THE LINOX LEAD.

Description of Event or Problem · 1

OUS MDR - THE ASSOCIATED LEAD WAS REMOVED FOR OVERSENSING AND AT THAT TIME, THIS LEAD WAS ALSO REMOVED. THIS LEAD HAD BEEN DEACTIVATED ON (B)(6) 2011, ALSO FOR OVERSENSING. BOTH LEADS WERE RETURNED FOR ANALYSIS AND THERE WERE NO ADVERSE PT EFFECTS REPORTED FOR THIS PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KENTROX RV-S 65 STEROID	ICD LEAD	NVY	BIOTRONIK SE & CO. KG	343080

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization