FDA Adverse Event Injury Summary report: N

DEXTRUS 4135

MDR report key: 3070485 · Received April 22, 2013

Report

Report Number: 1028232-2013-01074
Event Type: Injury
Date Received: April 22, 2013
Date of Event: February 25, 2013
Report Date: April 9, 2013
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVN
PMA / PMN Number: P950037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE 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. 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 AN UNRELATED PROCEDURE, THIS RIGHT ATRIAL LEAD EXHIBITED NO SENSING AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. A LEAD DISLODGEMENT WAS SUSPECTED. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED PROGRAMMING AND INVASIVE OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS PROGRAMMED OFF. AVAILABLE INFORMATION INDICATES THAT THIS LEAD REMAINS IMPLANTED. 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
171808	DEXTRUS 4135	PACER LEAD	NVN	BIOTRONIK SE & CO. KG	358744

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| O