CAPSUREFIX NOVUS

Report

Report Number: 2649622-2012-15288
Event Type: Injury
Date Received: October 15, 2012
Date of Event: August 8, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S017
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, 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, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THERE WAS TISSUE ON THE HELIX AND THERE WAS APPARENT EXPLANT DAMAGE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A POST IMPLANT CHECK INTERROGATION SHOWED NO CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD AND THE PATIENT'S HEART RATE WAS IN THE 30'S. THE RV LEAD HAD LOST SLACK AND WAS DISLODGED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD FUNCTIONED NORMALLY BUT FLUOROSCOPY NOTED THAT THE LEAD HAD LOST ITS SLACK. WHILE THE RV LEAD WAS BEING REPOSITIONED THE PHYSICIAN ELECTED TO REPOSITION THE RA LEAD AS WELL. ACCESS AND REPOSITION WAS DIFFICULT WITH VERY TIGHT ACCESS NEAR THE CLAVICLE. AFTER TRYING SEVERAL DIFFERENT RA LOCATIONS, THE PHYSICIAN ELECTED TO PLACE A TINED LEAD INSTEAD. THE RV LEAD REMAINS IN USE, AND THE RA LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Hospitalization\| R	ADDR01 IMPLANTABLE PULSE GENERATOR