FDA Adverse Event
Injury
Summary report: N
EXCLAIM 8
MDR report key: 3121890
·
Received May 15, 2013
Report
- Report Number
- 1627487-2013-05687
- Event Type
- Injury
- Date Received
- May 15, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 22, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT IS UNABLE TO RECEIVE ADEQUATE COVERAGE DUE TO EXPERIENCING UNCOMFORTABLE ABDOMINAL STIMULATION. THE PATIENT WILL MEET WITH AN SJM REPRESENTATIVE TO ADDRESS THE ISSUE VIA REPROGRAMMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215039 | EXCLAIM 8 | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3224 | 3601633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | IMPLANT:| SCS IPG: MODEL 3788 |