BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4051349 · Received September 2, 2014

    Report

    Report Number
    3004209178-2014-16213
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 7, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V476625, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT # V458446, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD TURNED OFF ON ITS OWN. THIS HAD FIRST OCCURRED ON (B)(6) 2014. THE PATIENT WAS ABLE TO TURN THE DEVICE BACK ON THE PATIENT PROGRAMMER. IT WAS NOTED THAT IT HAD OCCURRED AGAIN ON (B)(6) 2014 AND THE PATIENT WAS NOT ABLE TO TURN IT BACK ON WITH THE PROGRAMMER. THE CLINICIAN PROGRAMMER WAS ABLE TO TURN IT ON AND IMPEDANCE CHECK WAS DONE. IMPEDANCES WERE FOUND TO BE WITHIN NORMAL LIMITS. THE PHYSICIAN WAS PLANNING TO PERFORM X-RAYS ON THE BATTERY HEAD AND EXTENSIONS. THE PATIENT WAS ALIVE WITH NO INJURY. THERE WAS LESS THAN 50% THERAPY RELIEF AT AN UNKNOWN LOCATION. IT WAS LATER REPORTED THAT THE PATIENT FELT THAT THE INS HAD ¿CUT OFF¿ 5 TIMES IN THE PAST WEEK PRIOR TO THE DATE OF THIS REPORT. THE PATIENT HAD CONFIRMED WITH THE PATIENT PROGRAMMER. THE INS VOLTAGE WAS 2.8V. THE PATIENT HAD GONE TO THE EMERGENCY ROOM DUE TO THE ISSUE ON THE NIGHT PRIOR TO THE DATE OF THIS REPORT. THE PATIENT WAS COMPETENT WITH THE PATIENT PROGRAMMER AND THEY DID NOT THINK THAT THE PATIENT WAS PRESSING THE WRONG BUTTON. THE ISSUE WAS UNRESOLVED AND THE MANUFACTURING REPRESENTATIVE WAS GOING TO INTERROGATE THE BATTERY ON THE DATE OF THIS REPORT. IT WAS CONFIRMED THAT THE INS TURNING OFF HAD HAPPENED TWICE THE WEEK PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT EACH INSTANCE HAD SEEMED AS THOUGH IT WAS RELATED TO THE POSITIONAL CHANGE. WHEN THE PATIENT HAD ATTEMPTED TO TURN THE INS ON WITH THE PROGRAMMER HE HAD SEEN A CALL YOUR CLINICIAN SCREEN BUT DID NOT REMEMBER WHAT CODE HAD ACCOMPANIED THE SCREEN. IMPEDANCE FOR THE LEFT BRAIN WERE C/0-1293 OHMS, C/1-1423 OHMS, C/2-1266 OHMS, C/3-1342 OHMS, 0/1-1927, 0/ 2-2195 OHMS, 0/3-2396 OHMS, 1/2- 1911 OHMS, 1/3-2461 OHMS AND 2/3-1911 OHMS. THE PATIENT WAS PROGRAMMED AT C+0-, 3.0V, 90PW, AND 140 HZ. THE RIGHT SIDE WAS C/8-1198 OHMS, C/9-1080 OHMS, C/10-1006 OHMS, C/11-1121 OHMS, 8/9-1536 OHMS, 8/10-1712 OHMS, 8/11-2065 OHMS, 9/10-1358 OHMS, 9/11-1839 OHMS AND 10/11-1337 OHMS. THE PATIENT HAD HAD CERVICAL SPINE SURGERY A YEAR PRIOR TO THE DATE OF THIS REPORT. STIMULATION WAS OFF AND CHECK DEVICE CLOCK WAS NOTED. STIMULATION WAS LOST SUDDENLY AND THE PATIENT HAD GONE TO THE HOSPITAL TO GET IT TURNED BACK ON. THERE WAS NO INDICATION OF A POWER ON RESET (POR). THE PREVIOUS CLINICIAN PROGRAMMER SESSION AS ON (B)(6) 2000. THE DATE WAS RESET 7 DAYS PRIOR TO THE DATE OF THIS REPORT AND THE DATE OF THE CLINICIAN PROGRAMMER SESSION WAS (B)(6) 2000. THE CLOCK WAS LOST 7 DAYS PRIOR TO THE DATE OF THIS REPORT AND IT LOOKED LIKE THE POWER ON RESET DIAGNOSTIC WAS CLEARED 5 DAYS PRIOR TO THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533870 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR