BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1872233 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07991
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Report Date
    September 18, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE WAS SWITCHED OFF BY HER MOBILE PHONE. THE PT IMMEDIATELY FELT THE RETURN OF HER TREMOR AND WAS ABLE TO SWITCH HER GENERATOR BACK ON WITH HER MOBILE PHONE. THE IMPLANT WAS LOCATED ON THE RIGHT SIDE OF HER ABDOMEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT IMMEDIATELY RECOGNIZED THAT HER DEVICE HAD TURNED OFF BECAUSE, SHE EXPERIENCED HER TREMOR RETURN. THE PATIENT WAS ABLE TO USE HER MOBILE PHONE TO TURN THE IMPLANTABLE NEUROSTIMULATOR BACK ON. THE OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2011. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT. 2012 (B)(6): OC NEURO INTERFACE UPDATE SEVERITY: NEW: MODERATE OLD: (B)(6) 2012 OC NEURO INTERFACE UPDATE: OUTCOME: NEW: RESOLVED WITHOUT SEQUELAE RESOLVED DATE: (B)(6) 2011 2012 (B)(6) E-MAIL: REP REPORTS ON SATURDAY, (B)(6), PATIENT HELEN CASSEL, REPORTED THAT HER GENERATOR WAS SWITCHED OFF ACCIDENTALLY WITH HER MOBILE TELEPHONE. SHE RECOGNIZED IT IMMEDIATELY AS HER TREMOR RETURNED. SHE WAS ABLE TO USE HER MOBILE PHONE AGAIN TO TURN THE GENERATOR BACK ON. SHE IS IMPLANTED WITH A 37601 ACTIVA PC IN HER RIGHT ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ105683N| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD : MODEL 3389S-40, LOT# V475905| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN007360V| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V475905| EXTENSION: MODEL 37085, LOT# NKN007359V