FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2033247
·
Received March 30, 2011
Report
- Report Number
- 3006630150-2011-00428
- Event Type
- Injury
- Date Received
- March 30, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 10, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT WAS EXPLANTED DUE TO NOT RECEIVING ADEQUATE PAIN RELIEF. THE DEVICE WAS WORKING PROPERLY AND THE PATIENT WAS REPORTEDLY DOING FINE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2218-50 (B)(4) MODEL DESCRIPTION:ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO AN EXPLANT PROCEDURE. NO FURTHER DETAILS WERE PROVIDED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO AN EXPLANT PROCEDURE. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |