BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2182198 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05174
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AT THE LOCATION OF THE RIGHT-SIDE IMPLANTABLE NEUROSTIMULATOR. INITIALLY, THE SHOCKING SENSATION OCCURRED ONLY WHEN THE THERAPY STATUS WAS CHECKED USING ACCESS REVIEW. ON (B)(6) 2011, THE PATIENT EXPERIENCED THE SENSATION AT THE DEVICE SITE, WHILE SITTING IN CHARI. THE STIMULATION WAS TURNED OFF FOR ABOUT TEN MINUTES. WHEN THE THERAPY WAS TURNED BACK ON, THE ISSUE HAD RESOLVED. THE PATIENT HAD HISTORY OF FALLING DURING THE DAY, AND A SLEEP DISORDER THAT CAUSED THE PATIENT TO FALL OUT OF BED. THERE HAD BEEN NO RECENT FALLS, HOWEVER, IT WAS LATER REPORTED THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE AND THE PHYSICIAN. THE PATIENT EXPERIENCED A DIMINISHED THERAPEUTIC RESPONSE. ALSO, THE SHOCKING SENSATION FELT AT THE DEVICE SITE, TRAVELED DOWN THE ARM. PALPATION DID NOT RECREATE THE SHOCKING SENSATION. IT WAS NOT POSSIBLE TO REPROGRAM THE PATIENT'S DEVICE AND PREVIOUS CHANGES IN PROGRAMMING DID NOT ALLEVIATE THE ISSUE. ALL IMPEDANCE READINGS WERE WITHIN NORMAL LIMITS. A DIFFERENT ACCESS REVIEW WAS USED TO CHECK THE PATIENT'S SYSTEM WITH THE SAME RESPONSE. AS OF THE DATE OF THIS REPORT, THERE WAS NO "CLEAR EVIDENCE" TO PERFORM ANY SURGICAL INTERVENTION. NO CHANGES WERE MADE AND THE PATIENT CONTINUED WITH THE DEVICE TURNED ON. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR IMPLANT DATE:| LEAD: MODEL 3389S-40, LOT #V130326| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| LEAD: MODEL 3389S-40, LOT #V167785| LOT #VNFW151082H| IMPLANT DATE:| IMPLANT DATE:| PROGRAMMER: MODEL 7438, LOT #NHL017717P| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXTENSION: MODEL 7482A51, LOT #NHU149310V| EXTENSION: MODEL 7482A51, LOT #NHU180898V| LEAD: MODEL 3389S-40, LOT #V130326