FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 2203510
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-12348
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Removal / Correction Number
- Z-0068-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED MANY INAPPROPRIATE SHOCKS. IT WAS ALSO REPORTED THAT THERE WAS AN APPARENT LEAD FRACTURE, THE LEAD INTEGRITY ALERT TRIGGERED, THERE WAS HIGH RESISTANCE/IMPEDANCE, OVERSENSING, AND NOISE. DURING THE REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO RETRACT THE SCREW AND THE DAMAGED LEAD WAS LEFT IN PLACE AND CAPPED. A NEW LEAD WAS IMPLANTED. 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 | 73 YR | Hospitalization| R | 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD |