SETROX S 53

MDR report key: 2872106 · Received December 4, 2012

Report

Report Number: 1028232-2012-03111
Event Type: Injury
Date Received: December 4, 2012
Date of Event: September 6, 2012
Report Date: November 20, 2012
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVN
PMA / PMN Number: P950037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

OUS MDR.

Additional Manufacturer Narrative · 1

UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED SLIGHT DEFORMATIONS OF THE CONDUCTOR COIL WHICH OCCURRED MOST LIKELY DURING SURGERY. DURING ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN PARTICULAR, THE FIXATION HELIX COULD BE PROPERLY EXTENDED AND RETRACTED. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

Description of Event or Problem · 1

OUS MDR - IT WAS REPORTED THAT THIS LEAD HAD DISLODGED AND A REVISION WAS SCHEDULED. HOWEVER, REPOSITIONING WAS NOT POSSIBLE DUE TO AN ISSUE WITH THE HELIX. THERE WAS NO EXPLANT DATE PROVIDED AND NO MENTION OF EXPLANT. THIS IS ALL OF THE AVAILABLE INFO AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SETROX S 53	PACER LEAD	NVN	BIOTRONIK SE & CO. KG	350974

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization