ACTIVA
Report
- Report Number
- 3004209178-2016-17843
- Event Type
- Injury
- Date Received
- August 30, 2016
- Date of Event
- August 5, 2016
- Report Date
- February 15, 2017
- 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
- AR, US
- Reporter Occupation
- OTHER
Narratives
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.
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.
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.
THIS EVENT IS NOW REPORTABLE FOR SERIOUS INJURY. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3389S-40, LOT# VA0670C, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# VA0670C, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A PATIENT VIA A MANUFACTURER REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A WORSENING OF PD SYMPTOMS AND A SUDDEN ONSET OF RIGIDITY ON HIS LEFT SIDE. THE PATIENT THOUGHT THAT IT WAS DUE TO A LOW BATTERY SO THE DEVICE WAS RECHARGED; THE ISSUE WAS NOT RESOLVED. AN IMPEDANCE TEST WAS PERFORMED AND RESULTED IN C<(>&<)>11 HAVING IMPEDANCE VALUES OF 3276 OHMS WHILE 9<(>&<)>10 MEASURED AT 99 OHMS. IMPEDANCES WERE TESTED AGAIN AT A HIGHER AMP AND RESULTED IN 117 OHMS AND 112 OHMS. THE PATIENT WAS REDIRECTED TO THE HEALTH CARE PROVIDER (HCP) FOR REPROGRAMMING.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE CONSUMER WAS GOING TO SEE THEIR NEUROLOGIST ON (B)(6) 2017 AND THEY WERE ANTICIPATING HAVING TO DO A LEAD REVISION.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR THE LEAD REVISION ON (B)(6) 2017.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS CONFIRMED THAT THE DEVICES WERE NOT EXPLANTED. NO OTHER INFORMATION WAS REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM THE REP REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) POST OPERATIVE IMPEDANCES SHOWED AS FOLLOWS. C<(>&<)>8 = 5235 OHMS, C<(>&<)>9 = 5411, C<(>&<)>10 = 6982, C <(>&<)>11 = 8175, 8<(>&<)>9 = 4035, 8<(>&<)>10 = 5373, 8<(>&<)>11 = 6591, 9<(>&<)>11 = 5411, 10<(>&<)>11 = 5590, C<(>&<)>0 = 1717, C<(>&<)>1 = 1700, C<(>&<)>2 = 1442, C<(>&<)>3 = 1838, 0<(>&<)>1 = 1649, 0<(>&<)>2 = 2144, 0<(>&<)>3 = 2605, 1<(>&<)>2 = 2278, 2<(>&<)>3 = 1586. EXTERNAL NEUROSTIMULATOR INTRA-OPERATIVE RESULTS WERE ALSO TAKEN WHICH SHOWED AS FOLLOWS. 0<(>&<)>1 = 5193 OHMS, 0<(>&<)>2 = 6695, 0<(>&<)>3 = 7701, 1<(>&<)>2 = 5533, 1<(>&<)>3 = 6191, 2<(>&<)>3 = 6979. THE HEALTHCARE PROVIDER (HCP) TESTED THE IMPEDANCES ON DATE NOTIFIED WHICH SHOWED THE LEAD AS BEING A PROBLEM, BUT THERE WAS NO PLAN TO REPLACE THE LEAD ON DATE NOTIFIED. NO ISSUE WAS SEEN WITH THE LEFT LEAD AND NO SYMPTOMS WERE ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 564923 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |