BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3102224 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07413
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    May 6, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V483953, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V508855, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND HAD AN INCREASE IN SYMPTOMS. IT WAS STATED THE PATIENT WAS SHAKING NEAR THEIR PARETHESIA AREA AND WERE VERY NERVOUS AFTER THEIR DEVICE WAS IMPLANTED. IT WAS NOTED THE PATIENT'S STATUS WAS "GOOD" AND SHE HAD ALREADY HAD TWO REPROGRAMMING SESSIONS WITH HER HEALTHCARE PROVIDER. IT WAS LATER REPORTED THE PATIENT HAD BEEN HAVING ANXIETY ATTACKS, BUT THEY GOT BETTER WHEN THE PATIENT TOOK XANEX. IT WAS ALSO STATED THE PATIENT'S LEFT SIDE INCISION HAD BEEN RUBBING ON HER PILLOW. IT WAS ALSO NOTED THE PATIENT'S CROHN'S DISEASE HAD "FLARED UP" AND THE PATIENT WAS BEING TREATED FOR THOSE SYMPTOMS. A FEW MONTHS LATER, IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR HAD BEEN "ADJUSTED" BY THE HEALTHCARE PROVIDER ON (B)(6) 2011 AND THE PATIENT LEFT WITH EFFECTIVE THERAPY AND WAS "DOING FINE." IT WAS ALSO REPORTED NO DEVICE MALFUNCTIONS WERE FOUND AND NO FURTHER TESTING WAS NEEDED. IT WAS STATED THE PATIENT HAD SOME ANXIETY ISSUES. ADDITIONAL INFORMATION STATED THE PATIENT HAD THEIR DEVICES REMOVED "FOR A WHILE." IT WAS REPORTED THE PATIENT'S DEVICES WERE PUT IN ATONE TIME AND NOT IN STAGES. IT WAS THEN REPORTED THE PATIENT WAS UNSURE IF THE DEVICES WERE PUT IN AT ONE TIME OR IN STAGES. REPORTEDLY, THE PATIENT'S DEVICE "NEVER WORKED RIGHT," THE HEALTHCARE PROVIDER WASN'T ABLE TO GET IT PROGRAMMED OR ADJUSTED AND THERE WAS "SOMETHING WRONG" WITH ONE OF THE PATIENT'S LEADS. IT WAS STATED THE PATIENT'S DEVICES HAD BEEN REMOVED. THE PATIENT HAD TWO IMPLANTABLE NEUROSTIMULATORS. PLEASE REFERENCE REGULATORY REPORT #3004209178-2013-07411.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203158 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention