FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 8778716
·
Received July 10, 2019
Report
- Report Number
- 3006630150-2019-03440
- Event Type
- Injury
- Date Received
- July 10, 2019
- Date of Event
- June 18, 2019
- Report Date
- July 10, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-8116-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 143613, MODEL/CATALOG DESCRIPTION: ARTISAN SURGICAL LEAD 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THE REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571826 | PRECISION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | 165075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |