PRECISION®
Report
- Report Number
- 3006630150-2013-01064
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 1, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT THE MISSING CONTACT WAS RETRIEVED FROM THE PATIENT'S BODY.
DEVICE EVALUATION INDICATED THAT THE LEAD REVEALED AN ELECTRODE WAS COMPLETELY DISLODGED FROM THE PADDLE. VISUAL INSPECTION REVEALED DISTAL ELECTRODES WERE PARTIALLY DISLODGED FROM THE PADDLE SILICONE, BUT STILL ATTACHED TO THEIR RESPECTIVE CABLES. ONE ELECTRODE AND THE PROXIMAL TAILS WERE NOT RETURNED.
A REPORT WAS RECEIVED THAT DURING THE PATIENTS' REVISION, PADDLE LEAD REVEALED 7 CONTACTS AND ONE CONTACT FELL OFF. THE PHYSICIAN REPLACED THE LEAD AND WAS DOING WELL POST OPERATIVELY. IT WAS UNKNOWN IF THE MISSING CONTACT WAS RETRIEVED OR LEFT INSIDE THE PATIENT'S BODY.
A REPORT WAS RECEIVED THAT DURING THE PATIENTS' REVISION, PADDLE LEAD REVEALED 7 CONTACTS AND ONE CONTACT FELL OFF. THE PHYSICIAN REPLACED THE LEAD AND WAS DOING WELL POST OPERATIVELY. IT WAS UNKNOWN IF THE MISSING CONTACT WAS RETRIEVED OR LEFT INSIDE THE PATIENT'S BODY.
A REPORT WAS RECEIVED THAT DURING THE PATIENTS' REVISION, PADDLE LEAD REVEALED 7 CONTACTS AND ONE CONTACT FELL OFF. THE PHYSICIAN REPLACED THE LEAD AND WAS DOING WELL POST OPERATIVELY. IT WAS UNKNOWN IF THE MISSING CONTACT WAS RETRIEVED OR LEFT INSIDE THE PATIENT'S BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232586 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8216-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |