FDA Adverse Event
Malfunction
Summary report: N
CAPSURE Z NOVUS
MDR report key: 2791046
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14799
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S38
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A VENTRICULAR LEAD WARNING AND A POLARITY SWITCH. THE VENTRICULAR LEAD HAD LOW IMPEDANCES, NO R-WAVES WERE NOTED, AND THE THRESHOLD WAS HIGH AND VARIABLE. IT WAS ALSO REPORTED THAT THE P-WAVE WAS SMALL ON THE ATRIAL LEAD. THE LEADS REMAIN IN USE. 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 Z NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | SEDR01 IMPLANTABLE PULSE GENERATOR |