FDA Adverse Event
Injury
Summary report: N
LINEAR
MDR report key: 8855443
·
Received August 2, 2019
Report
- Report Number
- 3006630150-2019-03985
- Event Type
- Injury
- Date Received
- August 2, 2019
- Date of Event
- July 11, 2019
- Report Date
- August 2, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767695
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AGE AT TIME OF EVENT: (B)(6) YEARS OLD. MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 5083175. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 649093 | LINEAR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2158-50 | 17354425 | 08714729767695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |