BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4827966 · Received June 9, 2015

    Report

    Report Number
    3004209178-2015-10550
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37791, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER; PRODUCT ID 37751, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 37092, LOT# 279290002, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 64001, LOT# N259664, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER. (B)(4).

    Description of Event or Problem · 1

    (B)(4) 2015 CRTS 3231671, CRTS 3236857, RPL (CON, REP): IT WAS REPORTED THAT THERE WAS A COMMUNICATION PROBLEM BETWEEN THE RECHARGER AND IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT SUDDENLY HAD DIFFICULTY GETTING COMMUNICATION AND WHEN SHE DID GET IT SHE WOULD LOSE IT WITH THE SLIGHTEST MOVEMENT. THE PATIENT DENIED ANY SITE ISSUE OR RECENT TRAUMA, BUT STATED THERE WAS MAYBE A 1CM STRETCH AT THE INS POCKET. THE PATIENT WAS ABLE TO CONNECT WITH HER PATIENT PROGRAMMER AND CONFIRMED THAT HER DEVICE WAS ON AND OKAY. THE PATIENT HAD HER RECHARGER ANTENNA REPLACED AND CONTINUED TO HAVE DIFFICULTY RECHARGING. HER ORIGINAL ANTENNA WAS NOT RETURNED, C500. WITH THE NEW ANTENNA THE PATIENT WOULD GET 8 COUPLING BARS FOR ABOUT 1-2 MINUTES AND THEN NO COMMUNICATION WITH HER RECHARGER WITHOUT ANY MOVEMENT. IT WOULD NOT INTERROGATE, THE ANTENNA WAS SENT BUT HAD NOT FIXED THE ISSUE. THERE WAS NO PATIENT INJURY. THE PATIENT WAS USING ADHESIVE PADS WHICH HAD WORKED WELL IN THE PAST. THE RECHARGING HOLSTER DISPLAYED NO COMMUNICATION. NO INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. (B)(4) 2015 MPXR 260373, RPL (CON, REP): IT WAS LATER REPORTED THAT THERE WAS A COMMUNICATION/TELEMETRY ISSUE/COUPLING ISSUE. THERE WAS AN ACTION PLANNED BUT WAS NOT YET TAKEN. THE PATIENT WAS GOING TO CALL ON MONDAY FOLLOWING THE DATE OF THIS REPORT AND WOULD GET IN TO SEE THEIR NEUROLOGIST. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED BUT WOULD BE IN THE FUTURE. THE ISSUE WAS NOT RESOLVED AND THE CAUSE WAS NOT DETERMINED. THE PATIENT HAD THE SAME ISSUE SEVERAL WEEKS PRIOR TO THE DATE OF THIS REPORT AND WAS UNABLE TO MAINTAIN COUPLING FOR MORE THAN A FEW MINUTES. THIS WAS VERIFIED DESPITE MULTIPLE ATTEMPTS AND INTERVENTIONS. A NEW CHARGER UNIT HAD BEEN SENT TO THE PATIENT AND IT WORKED WELL UNTIL ON THE MORNING OF THE DATE OF THIS REPORT THE PATIENT HAD THE SAME ISSUE RETURN. UPON RETURN OF THE RECHARGER, ANALYSIS FOUND THE COMPLAINT WAS UNVERIFIED, THERE WAS AN E.C.O. UPDATE/CHANGE TO THE SOFTWARE, FACE PLATE AND LABEL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372028 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR