BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 977975 · Received January 10, 2008

    Report

    Report Number
    3004209178-2008-00120
    Event Type
    Malfunction
    Date Received
    January 10, 2008
    Date of Event
    December 1, 2007
    Report Date
    December 11, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING EXPOSURE TO THEFT SECURITY GATES AT A CELL PHONE STORE. THE PT'S DAUGHTER HAD REQUESTED COMPATIBILITY INFO FROM THE COMPANY REGARDING EMI AND MAGNETS AFTER PT SYMPTOMS HAD RETURNED. THE PT WAS AT THE CLINIC; HER CONDITION WAS DEEMED TO BE FAIR. THE REP REVIEWED THAT STIMULATION COULD BE REPROGRAMMED AND REDIRECTED THE PT TO FOLLOW-UP WITH THE HCP. THE HCP REPORTED THE PT HAD EXPERIENCED A RETURN OF SYMPTOMS; WHEN THE DEVICES HAD TURNED OFF, HER FACIAL PAIN HAD RETURNED. SHE HAD CHECKED THE PRODUCTS WITH THE PROGRAMMER; BOTH DEVICES WERE OFF. THE PT PROGRAMMER DEVICE WAS USED BY THE PT TO TURN THE PRODUCTS BACK ON. THE PT HAD BEEN ABLE TO INDICATE THERE WAS A PROBLEM; THE PAIN HAD INCREASED FROM ZERO (WITH THERAPY ON), TO LEVEL SEVEN. THE PAIN HAD IMPROVED WHEN THE DEVICES WERE ON; THE PT HAD "EXPERIENCED AN INCREASE IN INTENSITY WHEN DEVICES ARE OFF." THE DEVICES APPEARED TO FUNCTION WELL AFTER THE EVENT. DEVICE SETTINGS AND MODE OF TREATMENT REPORTED WERE: VPM 1.5V, 150 PW, 100 PR +C, 321 PVA 4 V, 120 PW C+ 321, PR 135. THE LOCATION AND METHOD OF TREATMENT WERE VPM AND PVA, FOR INTRACTABLE FACIAL PAIN. AFTER THE LAST PROGRAMMING, THE PT'S PAIN LEVEL WAS FOUR. REFER TO MFR REPORT #3004209178200800121.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INLINE EXTENSION MODEL 3550-05 LOT#N097408| EXPLANTED| IMPLANTED| LEAD MODEL 3387 LOT#V020088| EXPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 7482 LOT#NHU153791V| EXTENSION MODEL 7482 LOT#NHU153140V| IMPLANTED| IMPLANTED| INLINE EXTENSION MODEL 3550-05 LOT#N121174| IMPLANTED| LEAD MODEL 3387 LOT#V018816| IMPLANTED| EXPLANTED