FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 6192550
·
Received December 21, 2016
Report
- Report Number
- 3006630150-2016-03836
- Event Type
- Injury
- Date Received
- December 21, 2016
- Date of Event
- December 5, 2016
- Report Date
- December 5, 2016
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8352-50, SERIAL/LOT#: (B)(4), DESCRIPTION: COVEREDGE X 32, 50 CM 4X8 SURGICAL LEAD.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. NO FURTHER INFORMATION COULD BE OBTAINED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO A STOMACH INFECTION. ACCORDING TO THE CLINICAL FIELD SPECIALIST THE STOMACH INFECTION WAS NOT ASSOCIATED WITH THE PROCEDURE OR DEVICE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO A STOMACH INFECTION. ACCORDING TO THE CLINICAL FIELD SPECIALIST THE STOMACH INFECTION WAS NOT ASSOCIATED WITH THE PROCEDURE OR DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 843818 | PRECISION SPECTRA | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization |