FDA Adverse Event Malfunction Summary report: N

SELOX ST 60

MDR report key: 3880308 · Received June 18, 2014

Report

Report Number: 1028232-2014-01998
Event Type: Malfunction
Date Received: June 18, 2014
Date of Event: March 30, 2014
Report Date: June 6, 2014
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVN
PMA / PMN Number: P950037
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE LEAD UNDER COMPLAINT WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE AS WELL AS THE RECEIVED DATA. THE MANUFACTURING PROCESS FOR THIS LEAD WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. AT A NEXT STEP, THE RECEIVED DATA WERE INSPECTED. HIGH VALUES OF THE PACING IMPEDANCE AND PACING THRESHOLD WERE RECORDED FROM (B)(4) 2013. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE FOR ANALYSIS. IN SUMMARY, THE LEAD WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

Description of Event or Problem · 1

OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 66 MONTHS, A SUSPECTED LEAD FRACTURE WAS REPORTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS NOT RETURNED TO BIOTRONIK. ALL AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS EVENT WILL BE UPDATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357843	SELOX ST 60	PACER LEAD	NVN	BIOTRONIK SE & CO. KG	346367

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other