FDA Adverse Event Injury Summary report: N

DEXTRUS 4137

MDR report key: 3790104 · Received May 5, 2014

Report

Report Number: 1028232-2014-01451
Event Type: Injury
Date Received: May 5, 2014
Date of Event: March 21, 2014
Report Date: April 23, 2014
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 THIS RIGHT VENTRICULAR LEAD EXHIBITED AN IMPEDANCE INCREASE, INCREASED THRESHOLDS AND OCCASIONAL NOISE WITH OVERSENSING IN BIPOLAR. REPROGRAMMED TO UNIPOLAR AND NOISE ISSUE RESOLVED. THERE WERE NO ADVERSE PATIENT EFFECTS. 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
267397	DEXTRUS 4137	PACER LEAD	NVN	BIOTRONIK SE & CO. KG	358764

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization