FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 15865252
·
Received November 25, 2022
Report
- Report Number
- 3006630150-2022-06551
- Event Type
- Injury
- Date Received
- November 25, 2022
- Date of Event
- October 3, 2022
- Report Date
- November 25, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767749
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL:(B)(4). BATCH: 7083820.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION IN TARGETED AREA. THE PATIENTS LEADS WERE SUCCESSFULLY REVISED, HOWEVER, DEVELOPED BILATERAL UPPER EXTREMITY WEAKNESS POST-OPERATIVELY. THE PHYSICIAN IMMEDIATELY ADMITTED THE PATIENT BACK TO THE OPERATING ROOM (OR) AND REMOVED THE CERVICAL LEADS. A CERVICAL LAMINECTOMY WAS ALSO PERFORMED TO RELIEVE THE SYMPTOMS. THE PATIENT HAS BEEN UNDERGOING PHYSICAL THERAPY AND SYMPTOMS ARE IMPROVING. THE EXPLANTED LEADS WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2687977 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-70 | 7071595 | 08714729767749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Required Intervention |