CAPSURE Z NOVUS

Report

Report Number: 2649622-2014-09879
Event Type: Injury
Date Received: August 8, 2014
Date of Event: June 19, 2014
Report Date: June 19, 2014
Manufacturer: MPRI
Product Code: DTB
PMA / PMN Number: P850089
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: PRODUCT ID, 5554-53, IMPLANTED: (B)(6) 2002. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD BEEN REFERRED TO THE CLINIC DUE TO VENTRICULAR PACING FAILURE FOUND ON THE HOLTER MONITOR. NO CLEAR PACING FAILURE WAS FOUND IN THE VENTRICULAR CHANNEL, HOWEVER, THERE WERE OBSERVATIONS OF CROSSTALK CAUSED BY ATRIAL PACING FAILURE AND PREMATURE VENTRICULAR CONTRACTIONS (PVCS), WHICH MIGHT HAVE BEEN REGARDED AS VENTRICULAR UNDERSENSING DUE TO THE BLANKING PERIOD. OVERSENSING WAS ALSO NOTED. DURING THE EXPLANT OF THE ATRIAL LEAD, THE VENTRICULAR LEAD WAS SLIGHTLY AFFECTED IN THAT IT HAS MORE CURVE NOW. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. ADDITIONALLY, NUMEROUS PACING FAILURES WERE RECORDED ON THE ATRIAL LEAD. THERE WAS HIGH IMPEDANCE AND HIGH THRESHOLD. THE DOCTOR ATTEMPTED TO EXTRACT THE ATRIAL LEAD, USING A STYLET; IT WAS SOMEWHAT PULLED OUT BUT THE ELECTRODE AT THE TIP SEPARATED FROM THE ATRIAL LEAD. THE 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
467717	CAPSURE Z NOVUS	ELECTRODE, PACEMAKER, PERMANENT	DTB	MPRI	5054-58

Patients

Seq	Age	Sex	Outcome	Treatment
1	00085 YR		Hospitalization\| R	P1501DR IPG