ACTIVA
Report
- Report Number
- 3004209178-2018-11264
- Event Type
- Malfunction
- Date Received
- May 18, 2018
- Date of Event
- May 16, 2018
- Report Date
- May 18, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00613994761088
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389S-40, LOT# VA1NYZ0, IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, SERIAL/LOT #: VA1NYZ0, (B)(4). ALL CODES APPLY TO THE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL, MOVEMENT DISORDERS. IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES. THEY CHECKED THE IMPEDANCES ON 3 VOLTS AND 3 TIMES THERE WERE STILL HIGH IMPEDANCES IN CONTACT 2. CHECKED THE IMPEDANCES AGAIN AND RAN STIMULATED FOR 1 MIN ON 2 VOLTZ, THERE WERE STILL HIGH IMPEDANCES. OUT OF RANGE RESULTS ON ALL TESTS: 0 <(>&<)> 2 ¿ HIGH 1 <(>&<)> 2 ¿ HIGH 2 <(>&<)> 3 ¿ HIGH ALL RESULTS: 0 <(>&<)> 1 2502 0 <(>&<)> 2 11997 0 <(>&<)> 3 3290 1 <(>&<)> 2 11020 1 <(>&<)> 3 3085 2 <(>&<)> 3 12282 0 <(>&<)> 1 2519 0 <(>&<)> 2 12630 0 <(>&<)> 3 3290 1 <(>&<)> 2 11509 1 <(>&<)> 3 3085 2 <(>&<)> 3 13000 0 <(>&<)> 1 2519 0 <(>&<)> 2 13054 0 <(>&<)> 3 3304 1 <(>&<)> 2 11860 1 <(>&<)> 3 3073 2 <(>&<)> 3 13507 THE ISSUE WAS NOT RESOLVED AND THE LEAD WAS NOT REPLACED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368044 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37603 | 00613994761088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |