FDA Adverse Event Malfunction Summary report: N

DEXTRUS 4136

MDR report key: 2942135 · Received December 27, 2012

Report

Report Number: 1028232-2012-03490
Event Type: Malfunction
Date Received: December 27, 2012
Date of Event: November 1, 2012
Report Date: December 19, 2012
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVZ
PMA / PMN Number: P950037
Adverse Event: Yes
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 VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. THE PT FELL SHORTLY AFTER THE IMPLANT, THERE WERE NO IMPEDANCE CHANGE NOTED. THE FIELD REPRESENTATIVE SUSPECTS A MICRO-DISLODGEMENT. THE SENSITIVITY WAS INCREASED AND A REPOSITIONING PROCEDURE HAS BEEN SCHEDULED. THERE WERE NO ADDITIONAL ADVERSE PT EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. 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 4136	PACER LEAD	NVZ	BIOTRONIK SE & CO. KG	358754

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization