FDA Adverse Event Injury Summary report: N

DEXTRUS 4136

MDR report key: 3770129 · Received April 24, 2014

Report

Report Number: 1028232-2014-01337
Event Type: Injury
Date Received: April 24, 2014
Date of Event: March 3, 2014
Report Date: April 11, 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 PACEMAKER AND RIGHT VENTRICULAR LEAD EXHIBITED OVER-SENSED NOISE. THE PATIENT HAD SYNCOPE EPISODE BUT IT DID NOT REFLECT THE TIME OF THE EVENT. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED STRESSING THE LEAD WITH SEAT BELT MANEUVER AND MORE VIGOROUS ISOMETRICS. ABNORMAL NOISE WAS NOTED EVEN THOUGH DIAGNOSTICS AND THRESHOLDS WERE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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
249429	DEXTRUS 4136	PACER LEAD	NVN	BIOTRONIK SE & CO. KG	358754

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other