FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX NOVUS

MDR report key: 1864726 · Received October 12, 2010

Report

Report Number: 2649622-2010-10960
Event Type: Malfunction
Date Received: October 12, 2010
Date of Event: July 23, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S017
Removal / Correction Number: ASKU
Report Source: Manufacturer report
Reporter Location: OH, 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 ANALYSIS RESULTS FOUND NO ANOMALIES. LEAD WAS RETURNED WITH THE HELIX EXTENDED WITH BLOOD AND TISSUE. THE CONNECTOR PIN WAS BENT, HAD TO STRAIGHTEN TO ATTEMPT HELIX TESTING. THERE WERE ALSO BLOOD/BODY FLUIDS ON THE PROXIMAL CONNECTOR, THE OUTER INSULATION WAS BREACHED CUT, THE CONNECTOR PIN WAS BENT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, AND THE LEAD WAS STRETCHED. THE FULL LEAD WAS RETURNED FOR ANALYSIS. (B)(4) THE ANALYSIS RESULTS FOUND THE OUTER INSULATION BREACHED CUT. IN ADDITION THE PROXIMAL CONDUCTOR HAD BLOOD / BODY FLUID AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE FULL LEAD WAS RETURNED FOR ANALYSIS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING IMPLANT THE RIGHT VENTRICULAR LEAD (4076) HELIX WOULD NOT COMPLETELY EXTEND. THE LEAD WAS REPLACED. IT WAS ALSO REPORTED THAT DURING IMPLANT OF THE REPLACEMENT LEAD (5076) THERE WAS DIFFICULTY SPLITTING THE LEAD INTRODUCER AND THE LEAD WAS DAMAGED DURING IMPLANT. THE LEAD WAS REPLACED. 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.	4076	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	87 YR		Other