FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 1071991
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03807
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- May 26, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- Z-0067-007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING SEVERAL INAPPROPRIATE SHOCKS. THERE WAS OVERSENSING, RV PACING IMPEDANCE WAS 500-1800 OHMS, AND THERE WAS NO CAPTURE. DETECTIONS WERE TURNED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT RECEIVED 50 INAPPROPRIATE SHOCKS, AND THERE WAS A LEAD FRACTURE.
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 | Required Intervention | 4076 IMPLANTABLE PACING LEAD| D153ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB |