FDA Adverse Event
Malfunction
Summary report: N
PRECISION®
MDR report key: 3914695
·
Received July 3, 2014
Report
- Report Number
- 3006630150-2014-01528
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Date of Event
- June 6, 2014
- Report Date
- June 12, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT SCS WAS NOT WORKING BECAUSE OF MASSIVE LEAD MIGRATION. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S SPINAL CORD STIMULATOR (SCS) WAS NOT WORKING. THE PATIENT WILL UNDERGO LEAD REMOVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S SPINAL CORD STIMULATOR (SCS) WAS NOT WORKING. THE PATIENT WILL UNDERGO LEAD REMOVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S SPINAL CORD STIMULATOR (SCS) WAS NOT WORKING. THE PATIENT WILL UNDERGO LEAD REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391735 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |