FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 1071957
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03402
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- February 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ASKU
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS REMOVED AND REPLACED DUE TO OVERSENSING. ADDITIONAL INFORMATION REPORTED HIGH THRESHOLDS, HIGH IMPEDANCE, NO CAPTURE AND APPARENT CONDUCTOR FRACTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6943 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |