ACTIVA
Report
- Report Number
- 3004209178-2015-09098
- Event Type
- Injury
- Date Received
- May 14, 2015
- Report Date
- April 27, 2015
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA0K4XK, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# VA0E6GD, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_PROG, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).
IT WAS REPORTED THE PATIENT HAD AN INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) DEVICE POCKET IN THEIR CHEST. THE TYPE OF INFECTION WAS UNKNOWN AND ANTIBIOTIC TREATMENT WAS NECESSARY. ON (B)(6) 2015, THE PATIENT HAD SURGERY TO REMOVE THE INS AND PORTIONS OF THE EXTENSIONS. THE EXTENSIONS WERE CUT BEHIND THE EAR AND A PORTION REMAINED IMPLANTED AND CONNECTED TO THE LEADS. HOSPITALIZATION WAS REQUIRED. THE PATIENT WAS EXPECTED TO BE RE-IMPLANTED WITH AN INS AND EXTENSIONS ONCE THE INFECTION HAD CLEARED. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317310 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Hospitalization| R |