FDA Adverse Event Injury Summary report: N

CAPSURE SP

MDR report key: 2790605 · Received October 15, 2012

Report

Report Number: 2649622-2012-14750
Event Type: Injury
Date Received: October 15, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P830061/S12
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA
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.

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 PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS AND THERE WAS COSMETIC METAL ION OXIDATION AND ENVIRONMENTAL STRESS CRACKING ON THE INNER INSULATION. THE OUTER INSULATION HAD A WHITE SUBSTANCE ON IT AS WELL AS A COSMETIC DEPRESSION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD RECORDED 22 VENTRICULAR HIGH RATE EPISODES AND ONE EPISODE WAS NOTED TO HAVE NOISE. NOISE WAS ALSO NOTED ON THE RIGHT ATRIAL LEAD. THE RIGHT ATRIAL LEAD REMAINS IN USE. IT WAS LATER REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED AND 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	CAPSURE SP	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	4024

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Hospitalization\| R	5076 IMPLANTABLE PACING LEAD\| SDR303 IMPLANTABLE PULSE GENERATOR\| SDR303 IMPLANTABLE PULSE GENERATOR