FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 7039539
·
Received November 16, 2017
Report
- Report Number
- 3006630150-2017-04485
- Event Type
- Injury
- Date Received
- November 16, 2017
- Date of Event
- October 25, 2017
- Report Date
- May 10, 2018
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729764465
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-1132, SERIAL #: (B)(4), DESCRIPTION: PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT RECEIVED ANY MEDICAL INTERVENTION, AS THE PHYSICIAN DID NOT THINK IT WAS A BURN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT SUSTAINED A BURN FROM THE CHARGER WHILE CHARGING THE IMPLANT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT SUSTAINED A BURN FROM THE CHARGER WHILE CHARGING THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 817342 | PRECISION SPECTRA | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-5312 | NA | 08714729764465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |