ACTIVA
Report
- Report Number
- 3004209178-2014-04465
- Event Type
- Injury
- Date Received
- March 14, 2014
- Date of Event
- February 23, 2014
- Report Date
- February 23, 2014
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V062549, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD.
PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 64001, LOT# N247525, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 3387S-40, LOT# V062549, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD QUESTIONABLE IMPEDANCES THAT WERE CHANGING DEPENDING ON THE DAY THEY W ERE TAKEN. THEY WANTED TO DO A HEAD MRI DUE TO THE LEAD REVISION THAT WAS GOING TO HAPPEN THE MONDAY AFTER THE REPORT. IMPEDANCES WERE TAKEN AT 3 VOLTS AND COMBINATIONS WITH ELECTRODE 2 HAD IMPEDANCES AROUND 10,000 OHMS. ELECTRODE 2 WAS BEING USED IN PROGRAMMING AND THE PATIENT WAS NOT SEEING THERAPEUTIC RESULTS. THE PATIENT HAD PROFOUND TREMOR WITHOUT THERAPY. THEY WERE ABLE TO PROGRAM AROUND ELECTRODE 2, WHERE THE PATIENT STILL HAD SOME TREMOR PRESENT. IT WAS NOTED THAT DURING PREVIOUS TROUBLESHOOTING, THEY PRESSED ON THE HEADER BLOCK AND THE PATIENT LOST STIMULATION. IT WAS STATED THAT THEY DID A PROCEDURE AND TESTED THE LEAD IN AN EXTERNAL NEUROSTIMULATOR (ENS) AND SAW IMPEDANCES WITH ELECTRODE 2 AROUND 8,000 OHMS.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S LEAD WAS REPLACED. AT THE TIME OF THE REPORT THE PATIENT WAS RECOVERING FROM SURGERY AND WOULD FOLLOW-UP WITH HIS NEUROLOGIST. THE IMPEDANCE READINGS WERE ALL NORMAL NOW.
IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE ¿THERAPY WAS NOT WORKING.¿ THE PATIENT ALSO HAD A SORE SPOT JUST ABOVE THE LEAD AND EXTENSION CONNECTION, WHERE HE HAD PRESSED, AND NOW THERAPY WAS NOT WORKING FOR HIM. IT WAS UNKNOWN WHEN THIS OCCURRED AND THERE WERE NO FALLS OR TRAUMA. THE REPORTER NOTED THAT THE PATIENT HAD A STRONG RESTING TREMOR THAT WAS WELL CONTROLLED BY THERAPY, WHEN THERAPY WAS WORKING. A LEAD CONNECTION CHECK WAS DONE AND IMPEDANCES SHOWED FOUR OK. IT WAS CONFIRMED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON WITH PATIENT PROGRAMMER. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS MEETING HIS NEUROSURGEON THE DAY AFTER THE REPORT. THE FOLLOWING DAY, IT WAS REPORTED THAT THE PATIENT WAS PRESSING ON A SORE SPOT ON THE BACK OF HIS NECK AND THEN THERAPY STOPPED WORKING. THIS TOOK PLACE ON (B)(6) 2014 AT 8 AM CENTRAL TIME. ON THE DAY OF THE REPORT, THE PATIENT SAW SOME REDNESS, BUT HAD NO SORENESS. THE REPORTER STATED THAT THE SORENESS LOCATION WAS NOT NEAR THE EXTENSION SITE. THE INS BATTERY WAS FULLY CHARGED AND THE IMPEDANCES WERE WITHIN NORMAL LIMITS. THE PATIENT TURNED STIMULATION OFF AND ON, SET AT 0 FOR A SOFT START, AND HAD THE AMPLITUDE AT 4.9 VOLTS, BUT CONTINUED TO SEE NO RESPONSE. UPON INTERROGATION THERE WAS NO MESSAGE SEEN ON THE OBSERVATION SCREEN, NOR UPON THE SECOND INTERROGATION. THE ACTUAL BATTERY LEVEL OF THE INS WAS 3.905 VOLTS. THE REPORTER TRIED INCREASING STIMULATION TO 6 VOLTS AND SAW THE CHARGE DENSITY WARNING, BUT THE PATIENT CONTINUED TO SEE NO RELIEF AND IT WAS LIKE HE WAS AT BASELINE. THE NEXT DAY, IT WAS REPORTED THAT THEY THRESHOLD TESTED EACH OF THE CONTACTS AND FOUND THAT THE SYSTEM WAS INDEED FUNCTIONING. THE PATIENT LEFT HIS DOCTOR WITH NEW REPROGRAMMING THAT DID RESULT IN THE ARREST OF HIS RESTING TREMOR. THE PATIENT WAS TO FOLLOW-UP WITH HIS NEUROLOGIST. SIX DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT A WEEK AGO SPONTANEOUSLY. THE PATIENT HAD SIX YEARS OF STABLE THERAPY AND THEN HIS TREMOR STARTED BREAKING THROUGH. THE PATIENT¿S DISEASE HAD PROGRESSED OVER TIME AND HE HAD BOTH A RESTING AND ACTION TREMOR NOW, BUT DID HAVE A MARKED LOSS OF THERAPY A WEEK AGO. THE REPROGRAMMING THAT WAS TRIED SINCE THE THERAPY CHANGE DID HAVE SOME EFFECT ON THE PATIENT¿S TREMOR, BUT HE ALSO HAD SIDE EFFECTS. IT WAS NOTED THAT IMPEDANCES WERE ALL WITHIN THE NORMAL RANGE, BUT WHEN COMPARING PAST IMPEDANCES FROM TWO YEARS AGO THE IMPEDANCE WITH CONTACT 2 HAD RISEN IN A MARKED MANNER. THE PATIENT TENDED TO CHARGE DAILY AND THE CHARGE LEVEL WAS SHOWING 75% RECENTLY AND THE INS DID NOT APPEAR TO BE DEPLETING. THE PATIENT WAS GETTING SOME BENEFIT, BUT THEN HIS SYMPTOMS BLED THROUGH. ON THE DAY OF THE REPORT, THE PATIENT WAS INCREASED TO 4 VOLTS. THE PATIENT DID NOT HAVE ANY SHOCKING OR BURNING WITH STIMULATION, BUT HE NOTED THAT WHEN HE PRESSED ON AN AREA ON THE BACK OF HIS NECK WHERE HE HAD A ROSACEA SORE HE THOUGHT HIS STIMULATION THERAPY CHANGED AND WAS NOT GETTING ANY THERAPY AT ALL. THIS SORE WAS NOT NEAR THE PATIENT¿S THERAPY COMPONENTS. THE REPORTER STATED THAT THE PATIENT COULD GET BENEFIT USING OTHER ELECTRODES, BUT WHEN HE GOT HIGH ENOUGH IN VOLTAGE TO GET THERAPEUTIC BENEFIT HE HAD SIDE EFFECTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT ANOTHER ELECTRODE WAS USED AND THE PATIENT WAS RECEIVING THERAPY EQUIVALENT TO WHAT HE WAS RECEIVING PRIOR TO LOSS IN THERAPY. THE PATIENT WAS TO BE SEEN THE FOLLOWING WEDNESDAY AFTER THE REPORT FOR FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154331 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Required Intervention |