FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 2201405
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11107
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 13, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Removal / Correction Number
- Z-0067-0070-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 WAS WORKING ON AN AIR CONDITIONER AND RECEIVED A SHOCK DUE TO NOISE ON THE LEAD. THE ELECTROGRAM WAS SUGGESTIVE OF ELECTROMAGNETIC INTERFERENCE FROM THE AIR CONDITIONER. THE LEAD REMAINS IN USE. NO FURTHER 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 | 51 YR | Other | 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB |