FDA Adverse Event Injury Summary report: N

DEXTRUS 4137

MDR report key: 3874233 · Received June 16, 2014

Report

Report Number: 1028232-2014-01971
Event Type: Injury
Date Received: June 16, 2014
Date of Event: May 5, 2014
Report Date: June 5, 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

UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE INSPECTION DEMONSTRATED DEFORMATIONS OF THE INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN. THE SUBSEQUENT ANALYSIS INDICATED THAT THESE DAMAGES WERE CAUSED BY OVER-ROTATION. CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE OUTER COIL WERE FOUND WHICH OCCURRED MOST LIKELY DURING THE SURGERY. BLOOD PENETRATED THE LEAD. IN SUMMARY, THE INNER COIL OF THIS LEAD WAS FOUND TO BE DEFORMED. THIS DAMAGE AFFECTED THE ACTIVE FIXATION MECHANISM. NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM WAS PRESENT.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS DISLODGED. THE RV LEAD WAS EXPLANTED AND RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352129	DEXTRUS 4137	PACER LEAD	NVN	BIOTRONIK SE & CO. KG	358764

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization