FDA Adverse Event Injury Summary report: N

CAPSUREFIX NOVUS

MDR report key: 2810394 · Received October 31, 2012

Report

Report Number: 2649622-2012-15716
Event Type: Injury
Date Received: October 31, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, THE HELIX/LOBE WAS DISTORTED/BENT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE LEAD WAS RETURNED WITH THE HELIX FULLY EXTENDED, DISTORTED/BENT. THE DRIVE SHAFT AND SLEEVEHEAD WERE BENT. THEREFORE, THE HELIX FUNCTIONS COULD NOT BE TESTED. THE LEAD WAS DAMAGED AT IMPLANT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD AN ACUTE INCREASE IN IMPEDANCE AND HIGH THRESHOLD WHICH CHANGED THE DEVICE TO UNIPOLAR. THERE WAS AN APPARENT FRACTURE OF THE OUTER COIL. THE LEAD WAS CAPPED. DURING THE IMPLANT ATTEMPT OF THE REPLACEMENT LEAD, WHEN THE LEAD WAS REMOVED, THE HELIX WAS PARTIALLY EXTENDED WITH BLOOD IN THE SCREW MECHANISM. THE LEAD EXTENDED/RETRACTED APPROPRIATELY, BUT THE PHYSICIAN REQUESTED A NEW LEAD. THAT LEAD WAS NOT USED AND NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAPSUREFIX NOVUS	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	5076

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Hospitalization\| R	(B)(4) IMPLANTABLE PULSE GENERATOR\| (B)(4) IMPLANTABLE PACING LEAD