FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 2012405
·
Received March 9, 2011
Report
- Report Number
- 2649622-2011-03148
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 22, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Removal / Correction Number
- Z-0068-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
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 THE PATIENT HEARD THE DEVICE BEEPING. TRANSMISSION SENT TO CLINIC WHERE IT WAS NOTED THE RV COIL HAD BEEN TRENDING AT 50 - 60 OHMS AND THEN, SPIKED TO 125 OHMS. SINCE THEN, IT IS BACK TO 50 - 60 OHMS. THE LEAD REMAINS IN USE AND THE PATIENT IS GOING TO BE SEEN IN THE CLINIC. NO PATIENT COMPLICATIONS WERE 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. | 6931 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Other | 4076 IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB |