ACTIVA
Report
- Report Number
- 3004209178-2020-10925
- Event Type
- Injury
- Date Received
- June 24, 2020
- Date of Event
- June 23, 2020
- Report Date
- June 24, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00643169864191
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT#: VA0G4UU, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT#: V080811, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389S-40, SERIAL/LOT #: (B)(4), UBD: 20-NOV-2016, UDI#: (B)(4); PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 03-FEB-2018, UDI#: (B)(4); PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 17-MAY-2018, UDI#: (B)(4); PRODUCT ID: 3389S-40, SERIAL/LOT #: (B)(4), UBD: 12-DEC-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION OF THE LEAD/EXTENSION SITE BEHIND THE EAR. THERE WAS ALSO SKIN EROSION. THE WHOLE DBS SYSTEM WAS REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655707 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37601 | 00643169864191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |