FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA®
MDR report key: 4223071
·
Received November 4, 2014
Report
- Report Number
- 3006630150-2014-02560
- Event Type
- Injury
- Date Received
- November 4, 2014
- Date of Event
- September 18, 2014
- Report Date
- October 6, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S LEAD SPLITTER CONNECTOR HEADS WERE BURIED IN THE POCKET SITE WHICH BECAME BOTHERSOME. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE POCKET SITE WAS OPENED AND THE LEAD SPLITTER CONNECTOR HEADS WERE RELOCATED TO A DIFFERENT AREA. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-3400-30, SERIAL/LOT #: (B)(4), DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM).
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT POCKET REVISION FOR UNKNOWN REASON.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT POCKET REVISION FOR UNKNOWN REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 706172 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |