FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 1072881
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03650
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- April 2, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS DETECTED, WHICH WAS REPRODUCIBLE WITH ARM MOVEMENT. OVERSENSING AND LOW IMPEDANCE WAS ALSO INDICATED. THE LEAD WAS CAPPED AND 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 | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6945 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 7271 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6940 IMPLANTABLE PACING LEAD |