PRECISION SPECTRA
Report
- Report Number
- 3006630150-2017-02560
- Event Type
- Malfunction
- Date Received
- July 12, 2017
- Date of Event
- June 20, 2017
- Report Date
- June 20, 2017
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S BREAST PAIN AND BACK PAIN WERE PRE EXISTING. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL #: (B)(4). DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM SC-1132/106957: DEVICE EVALUATION INDICATED THAT THE RETURNED IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. SC-8216-50/483660: THE PADDLE LEAD BODY WAS CUT CLEANLY AND THE PADDLE PORTION WAS NOT RETURNED. THE DAMAGE WAS CONSIDERED EXPLANT DAMAGE. HOWEVER, A SETSCREW MARK WAS ON THE ELECTRODE #16.
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG INTERFERED WITH THE ELECTROCARDIOGRAM (ECG) PROCEDURE. THE PATIENT BELIEVED THAT THE IPG WAS NOT FUNCTIONING PROPERLY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED.
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG INTERFERED WITH THE ELECTROCARDIOGRAM (ECG) PROCEDURE. THE PATIENT BELIEVED THAT THE IPG WAS NOT FUNCTIONING PROPERLY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 488773 | PRECISION SPECTRA | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |