FDA Adverse Event
Injury
Summary report: N
SURETEK
MDR report key: 10803361
·
Received November 6, 2020
Report
- Report Number
- 3006630150-2020-05407
- Event Type
- Injury
- Date Received
- November 6, 2020
- Date of Event
- October 15, 2020
- Report Date
- November 6, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 08714729820802
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: (B)(4), MODEL: DB-1200-S, SERIAL: (B)(4), BATCH: 740530. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7071008. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: (B)(4), MODEL: DB-4605C, SERIAL: N/A, BATCH: 24510901. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 5174564.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT BANGED HER HEAD RIGHT ON THE BURR HOLE COVER. THE PATIENT THEN HAD EROSION AROUND HER BURR HOLE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE ENTIRE DBS SYSTEM. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1265085 | SURETEK | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION | DB-4600C | 24785976 | 08714729820802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |