ACTIVA
Report
- Report Number
- 3004209178-2016-17150
- Event Type
- Malfunction
- Date Received
- August 18, 2016
- Date of Event
- July 5, 2016
- Report Date
- August 18, 2016
- 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
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V346793, PRODUCT TYPE: LEAD. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A HEALTHCARE PROFESSIONAL (HCP) REPORTED A LEAD CONFIGURATION SWITCH, LEFT TO RIGHT AND VICE VERSA. THE LEFT SIDE IMPEDANCE WERE RECORDED AS C <(>&<)>0 3420 OHMS, C<(>&<)>1 1498 OHMS, C<(>&<)>2 821 OHMS, C<(>&<)>3 796 OHMS, 0<(>&<)>1 2774 OHMS, 0<(>&<)>2 3488 OHMS, 0 <(>&<)>3 3641 OHMS, 1<(>&<)>2 1449 OHMS, 1<(>&<)>3 1736 AND 2<(>&<)>3 961 OHMS. THE RIGHT SIDE IMPEDANCE WERE REPORTED AS C<(>&<)>8 1367 OHMS, C<(>&<)>9 792 OHMS, C<(>&<)>10 1367 OHMS, C<(>&<)>11 817 OHMS, 8<(>&<)>9 1690 OHMS, 8<(>&<)>10 33 OHMS, 8<(>&<)>11 1674, 9 <(>&<)>10 1690 OHMS, 9<(>&<)>11 1276 OHMS AND 10<(>&<)>11 1674 OHMS. THE HCP NOTED THAT SINCE THE CONFIGURATION SWITCH 0<(>&<)>2 NOW IS THE 8<(>&<)>10 STILL BEING AT 33 OHMS. THE HCP NOTED IT APPEARS TO BE A LEAD ISSUE. IT WAS ALSO NOTED THE PATIENT IS FEELING STIMULATION ALONG THE EXTENSION WHEN THERAPY IS ON. THE HCP PLANS TO DO AN X-RAY CHECK. IT WAS DISCUSSED CHECKING EXTENSION AND LEAD IF THERE IS TO BE ANOTHER REVISION. THERE WAS NO DATE SET FOR ANOTHER REVISION. IT WAS NOTED PATIENT HAS CONTROL OF TREMORS. THE PATIENT IS IMPLANTED FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 537288 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |