FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 4130610
·
Received September 30, 2014
Report
- Report Number
- 3006630150-2014-02268
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- September 4, 2014
- Report Date
- September 4, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE IMPLANTED PADDLE LEAD THAT WAS NOT CONNECTED TO AN IPG WAS NON-BSC LEAD.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD AN IMPLANTED LAMINOTOMY PADDLE ELECTRODE WHICH WAS NOT CONNECTED TO AN IPG. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD AN IMPLANTED LAMINOTOMY PADDLE ELECTRODE WHICH WAS NOT CONNECTED TO AN IPG. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 609382 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | NI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |