FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 2200574
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11030
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- January 22, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Removal / Correction Number
- Z-0070-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ASKU
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 T-WAVE OVERSENSING WAS RECORDED IN THE BEGINNING OF THIS YEAR. NO FURTHER EPISODES HAVE BEEN OBSERVED SINCE THAT TIME. IT WAS FURTHER REPORTED THAT THE T-WAVE OVERSENSING WAS DUE TO THE PATIENT'S ANATOMY. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT T-WAVE OVERSENSING WAS RECORDED IN THE BEGINNING OF THIS YEAR. NO FURTHER EPISODES HAVE BEEN OBSERVED SINCE THAT TIME. 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 | SPRINT FIDELIS | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6949 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Other | 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD |