FDA Adverse Event Injury Summary report: N

CAPSUREFIX

MDR report key: 2812080 · Received October 31, 2012

Report

Report Number: 2649622-2012-15909
Event Type: Injury
Date Received: October 31, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S2
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, 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 IN SEGMENTS, ANALYZED AND THE INNER INSULATION WAS BREACHED AND HAD METAL INDUCED OXIDATION. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE INNER INSULATION HAD COSMETIC METAL INDUCED OXIDATION, THE OUTER INSULATION HAD COSMETIC METAL INDUCED OXIDATION, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A RIGHT ATRIAL (RA) LEAD FAILURE. IT WAS ALSO REPORTED THAT THE RA LEAD HAD OVERSENSING AND LOW IMPEDANCE. WHEN MEASURED THROUGH THE ANALYZER THE LEAD ALSO HAD LOW P WAVES AND NO CAPTURE. THE RA LEAD WAS EXPLANTED AND REPLACED. IN ADDITION, THE RIGHT VENTRICULAR LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED PROPHYLACTICALLY. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION. 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	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	4568

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Hospitalization\| R	6949 IMPLANTABLE TACHY LEAD\| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB