FDA Adverse Event Malfunction Summary report: N

DEXTRUS 4137

MDR report key: 1901475 · Received November 9, 2010

Report

Report Number: 1028232-2010-02392
Event Type: Malfunction
Date Received: November 9, 2010
Report Date: October 18, 2010
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVZ
PMA / PMN Number: P950037
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS, THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE 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. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEXTRUS RIGHT VENTRICULAR LEAD IS FRACTURED AND IMPEDANCE MEASUREMENTS HAVE INCREASED FROM 530 OHMS TO 2320 OHMS AND THERE IS NO CAPTURE. THE PATIENT IS NOT PACEMAKER DEPENDENT AND THRESHOLDS ARE A LITTLE BETTER IN UNIPOLAR CONFIGURATION. THE CALLER STATED THAT THEY WILL KEEP THE LEAD PROGRAMMED TO A SPLIT CONFIGURATION UNTIL THE NEXT STEPS ARE DETERMINED BY THIS PATIENT'S PHYSICIAN. THE LEAD REMAINS ACTIVELY IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED. THE EVENT DATE THAT WAS REPORTED TO US, OCCURS BEFORE THE IMPLANT DATE. THEREFORE THE EVENT DATE WILL NOT BE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DEXTRUS 4137	PACER LEAD	NVZ	BIOTRONIK SE & CO. KG	358764

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other