FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 2812277
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16667
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS PROGRAMMED UNIPOLAR FOR "YEARS" DUE TO INCREASED CAPTURE THRESHOLD AND DECREASED SENSING. AN ATTEMPT WAS MADE TO PROGRAM TO BIPOLAR SENSING BUT LOSS OF CAPTURE WAS NOTED. IT WAS ALSO REPORTED THERE WAS A LEAD WARNING FOR LOW IMPEDANCE ALONG WITH VENTRICULAR HIGH RATES WITH OVERSENSING. FOLLOW UP CONFIRMED THE PATIENT HAS AN APPOINTMENT SCHEDULE TO REASSESS THE LEAD. THE LEAD REMAINS 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 | CAPSUREFIX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | 4068 IMPLANTABLE PACING LEAD| VEDR01 IMPLANTABLE PULSE GENERATOR |