SPRINT FIDELIS
Report
- Report Number
- 2649622-2011-05774
- Event Type
- Injury
- Date Received
- April 13, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Removal / Correction Number
- Z-0067-0070-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVER SENSING. VIEWED TRANSMISSION SHOWED T-WAVE OVER SENSING WITH VARIABLE R-WAVE AMPLITUDES AND INTERMITTENT R-WAVE UNDER SENSING. IT WAS ALSO REPORTED THAT THE LEAD'S IMPEDANCE INCREASED. THE LEAD WAS LEFT IN PLACE AND CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVER SENSING. VIEWED TRANSMISSION SHOWED T-WAVE OVER SENSING WITH VARIABLE R-WAVE AMPLITUDES AND INTERMITTENT R-WAVE UNDER SENSING. IT WAS ALSO REPORTED THAT THE LEAD'S IMPEDANCE INCREASED. THE LEAD WAS LEFT IN PLACE AND CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT FIDELIS | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6949 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |