FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 1792641
·
Received August 11, 2010
Report
- Report Number
- 2649622-2010-07049
- Event Type
- Injury
- Date Received
- August 11, 2010
- Date of Event
- April 20, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Removal / Correction Number
- Z-0067-0070-2008
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: (B)(4) DISTAL CONDUCTOR FRACTURED, DISTAL AND DEFIB CONDUCTORS FOUND DISTORTED, DEFIB CONDUCTOR WAS FRACTURED (OVERSTRESS), OUTER TUBING OVERLAY MELTED, AND BLOOD NOTED ON HELIX MECHANISM; FULL LEAD IN SEGMENTS ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS OVERSENSING AND HAD A DISLODGEMENT. POSSIBLE LEAD FRACTURE WAS NOTED. THE LEAD WAS REPLACED. 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. | 6949 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | D284TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD |