FDA Adverse Event
Injury
Summary report: N
SC-1110-02
MDR report key: 6994617
·
Received November 1, 2017
Report
- Report Number
- 3006630150-2017-04350
- Event Type
- Injury
- Date Received
- November 1, 2017
- Date of Event
- October 13, 2017
- Report Date
- November 14, 2017
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767688
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE NEW PAIN AREA WAS NOT CAUSED BY THE DEVICE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NEW BACK PAIN. IT WAS UNKNOWN IF THE NEW PAIN WAS DEVICE RELATED OR NOT. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NEW BACK PAIN. IT WAS UNKNOWN IF THE NEW PAIN WAS DEVICE RELATED OR NOT. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773378 | SC-1110-02 | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA | 08714729767688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |