FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3880728
·
Received June 18, 2014
Report
- Report Number
- 3006630150-2014-01360
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- May 27, 2014
- Report Date
- May 27, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S COVERAGE WAS GOOD, BUT WAS NOT HELPING WITH THE PAIN. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM. MODEL#: SC-4316, SERIAL #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR UNKNOWN REASON. DEVICE FAILURE WAS NOT SUSPECTED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR UNKNOWN REASON. DEVICE FAILURE WAS NOT SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 357302 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |