FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 2811885
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16886
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 8, 2012
- 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
- WA, 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 THAT THE RIGHT VENTRICULAR LEAD SUSTAINED A SMALL AMOUNT OF INSULATION DAMAGE DURING A DEVICE CHANGE-OUT PROCEDURE. THE DAMAGE WAS MINIMAL AND ELECTRICAL TESTING WAS STABLE WITH LEAD MANIPULATION. THE PHYSICIAN DECIDED TO DO NOTHING AND LEFT THE LEAD IN SERVICE. 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other | 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB |