FDA Adverse Event
Injury
Summary report: N
SC-1110-02
MDR report key: 6958387
·
Received October 18, 2017
Report
- Report Number
- 3006630150-2017-04059
- Event Type
- Injury
- Date Received
- October 18, 2017
- Date of Event
- September 28, 2017
- Report Date
- November 15, 2017
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767688
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8216-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR EXPLANT WAS THAT THE PATIENT WAS NO LONGER USING THE STIMULATOR AND DID NOT WANT IT ANYMORE. NO DEVICE MALFUNCTION WAS SUSPECTED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736887 | SC-1110-02 | SPINAL CORD STIMULATION | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA | 08714729767688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |