FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3413429
·
Received October 16, 2013
Report
- Report Number
- 3006630150-2013-02344
- Event Type
- Injury
- Date Received
- October 16, 2013
- Date of Event
- September 24, 2013
- Report Date
- September 25, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL:SC-2218-30, SERIAL/LOT: (B)(4) DESCRIPTION:LINEAR ST LEAD, 30CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REVISION DUE TO PAIN AT THE LOOP OF THE LEADS AND ANCHOR SITE. THE LEADS WERE UNPLUGGED FROM THE IPG, RE-TUNNELED AND RECONNECTED TO THE IPG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 530193 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-30 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |