ACTIVA
Report
- Report Number
- 3004209178-2015-13779
- Event Type
- Malfunction
- Date Received
- July 21, 2015
- Report Date
- June 29, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3389S-40, LOT# V884064, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V853915, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION (B)(4).
(B)(4).
IMPLANT DATE REPORTED WAS CORRECTED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3389S-40, LOT# V884064, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3389S-40, LOT# V853915, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER WHICH INDICATED AT IMPLANT ON (B)(6) 2015 THE HEALTHCARE PROFESSIONAL HAD TO PUT IN A SECOND SET OF WIRES THE SECOND SET HAD NOT WORKED CORRECTLY EITHER, THEY WERE DOING THE SAME THING AS THE FIRST SET. THERE HAD BEEN NO STEPS HAD BEEN TAKEN TO RESOLVE THE BAD CONNECTION AND WIRE NOT FIRING. THERAPY WAS WORKING WELL UNTIL A HEALTHCARE PROFESSIONAL APPOINTMENT ON (B)(6) 2015, THE SETTINGS WERE LOWERED TO 3.5V AND NOW THE PATIENT WAS DRAGGING HIS LEFT LEG MORE WHICH WAS CAUSING HIM TO FALL. THE PATIENT HAD TAKEN 2 BAD FALLS SINCE SEEING THEIR HEALTHCARE PROFESSIONAL ON (B)(6) 2015. FALLS OCCURRED ON (B)(6) 2015 AND ABOUT (B)(6) 2015. THE LEFT LEG HAD ALWAYS HAD A DRAG TO SOME DEGREE BUT IT SEEMED WORSE SINCE THE APPOINTMENT.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE CIRCUMSTANCES THAT LED TO THE LEG DRAGGING WAS A PROGRESSIVE OF PARKINSON'S DISEASE. THE ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE LEG DRAGGING WAS AN INCREASE IN DEEP BRAIN STIMULATION (DBS) PROGRAMMING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED BY THE PATIENT REPORTED THAT THE PATIENT SAW THEIR NEUROLOGIST ON (B)(6) 2015. THE NEUROLOGIST THOUGHT THERE MIGHT BE A SHORT IN ONE OF THE CONNECTIONS OR LEADS. AT THAT TIME THE VOLTAGE WAS DECREASED ON THE RIGHT SIDE OF THE CHEST TO 3.0 AND THE LEFT REMAINED UNCHANGED AT 4.4. THE VOLTAGE ON RIGHT SIDE WAS 2.8 AND LEFT SIDE WAS 2.89. ERRATIC READINGS WERE NOTICED. SINCE THE VISIT ON (B)(6) 2015 THE PATIENT FELL TWICE. THE PATIENT NOTED THAT SINCE HAVING THE ELECTRODES IMPLANTED IN HIS BRAIN HIS LIFE HAD IMPROVED 100%. THE INDICATIONS FOR USE (IFUS) ARE PARKINSONS DUAL AND MOVEMENT DISORDERS.
IMPLANT DATE REPORTED AS APRIL 3RD 2015 WAS UPDATED TO (B)(6) 2012.
IT WAS REPORTED THAT THE PATIENT WAS TOLD AT THEIR APPOINTMENT THE WEEK PRIOR TO THE DATE OF THIS REPORT THAT ONE OF THE CONNECTIONS WAS GOING BAD SO SHE HAD DROPPED THE VOLTAGE DOWN. REFERENCE MANUFACTURER'S REPORT NUMBER: 3004209178-2015-13776.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473914 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR |