FDA Adverse Event
Injury
Summary report: N
EXCLAIM 8
MDR report key: 2792167
·
Received October 11, 2012
Report
- Report Number
- 1627487-2012-06544
- Event Type
- Injury
- Date Received
- October 11, 2012
- Report Date
- August 13, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD FALLEN. AFTERWARDS, THE PT LOST STIMULATION. AN IMPEDANCE CHECK WAS PERFORMED AND REVEALED INVALID IMPEDANCE. DURING SURGICAL INTERVENTION, THE LEAD WAS FOUND TO BE KNOTTED. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. POST-OP IMPEDANCE WAS NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXCLAIM 8 | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3225 | 3153804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SCS IPG: MODEL: 3788| IMPLANT: |