FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 2790938
·
Received October 15, 2012
Report
- Report Number
- 2182208-2012-03285
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S13
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
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 PATIENT RECEIVED SHOCKS WHEN THE DEVICE WAS BEING INTERROGATED. IT WAS ALSO REPORTED THAT THE LEAD HAD A FRACTURE OF THE PACE/SENSE PORTION OF THE LEAD. THE HVB/HVX PORTION OF THE LEAD IS STILL IN USE AND ANOTHER LEAD WAS IMPLANTED FOR THE PACE/SENSE PORTION. NO PATIENT COMPLICATIONS HAVE BEEN 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| L| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |