DEXTRUS 4135

MDR report key: 2895999 · Received November 19, 2012

Report

Report Number: 1028232-2012-03002
Event Type: Malfunction
Date Received: November 19, 2012
Date of Event: September 12, 2012
Report Date: November 14, 2012
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVZ
PMA / PMN Number: P950037
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(6) 2018 - WE WERE NOTIFIED THAT THIS LEAD WAS EXPLANTED BUT NOT RETURNED FOR ANALYSIS.

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 RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE, THIS RIGHT ATRIAL LEAD PACING IMPEDANCE MEASUREMENT WAS 1,200 OHMS. CURRENTLY, THE PACING IMPEDANCE MEASUREMENT WAS GREATER THAN 2,000 OHMS, WITH QUESTIONABLE ATRIAL CAPTURE. THE PATIENT WAS SENT FOR A CHEST X-RAY AND RESULTS WERE NOT AVAILABLE FROM THE PHYSICIAN. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DEXTRUS 4135	PACING LEAD	NVZ	BIOTRONIK SE & CO. KG	358744

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other