FDA Adverse Event Malfunction Summary report: N

DEXTRUS 4135

MDR report key: 2942132 · Received December 27, 2012

Report

Report Number: 1028232-2012-03485
Event Type: Malfunction
Date Received: December 27, 2012
Date of Event: October 26, 2012
Report Date: December 19, 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: 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 RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD DISPLAYED AN INCREASE IN PACING IMPEDANCE FROM 571 OHMS TO 744 OHMS. THE LEAD ALSO DISPLAYED LOSS OF CAPTURE, A DECREASE IN INTRINSIC AMPLITUDE FROM 3.7 MV TO 0.9 MV AND MUSCLE STIMULATION. THE PT WAS TO BE SEEN FOR A CHEST X-RAY. FOLLOW UP FROM THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATED THAT THE PT HAS NOT YET HAD A CHEST X-RAY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED. 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	PACER LEAD	NVZ	BIOTRONIK SE & CO. KG	358744

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization