FDA Adverse Event
Malfunction
Summary report: N
SPRINT
MDR report key: 1861583
·
Received October 8, 2010
Report
- Report Number
- 2182208-2010-00721
- Event Type
- Malfunction
- Date Received
- October 8, 2010
- Date of Event
- July 7, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S13
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD RECORDED EPISODES OF NOISE ON THE EGM AS WELL AS OVERSENSING. THE CALLER REQUESTED HELP IN DETERMINING IF THIS WAS CONSISTENT WITH A LEAD FRACTURE OR EMI NOISE. THE DEVICE REMAINS IN USE. 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, INC. | 6945 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | 6940 IMPLANTABLE PACING LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |