BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3844002 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09987
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 12, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V805902, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BLACKED OUT ON MONDAY PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT THE PATIENT HAD EPISODES OF DYSTONIC SEIZURES THAT LASTED 45-50 SECONDS. IT WAS FURTHER NOTED THAT THE PATIENT HAD BLACKED OUT A FEW TIMES SINCE MONDAY PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT SOMEONE AT THE HOSPITAL THOUGHT THE RIGHT IMPLANT HAD A SHORT. THE PATIENT WOULD NOT GET THE DEVICE RESET OR CHECKED FOR 2 WEEKS. THE PATIENT FELL 2 MONTHS PRIOR TO THE DATE OF THIS REPORT BUT THEY DID NOT THINK THIS WAS RELATED TO THE CURRENT INCIDENT. PATIENT¿S STATUS WAS UNKNOWN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. IT WAS LATER REPORTED THAT THE PATIENT WAS ¿HAVING SEIZURES BECAUSE OF A FAULTY UNIT.¿ THIS HAD STARTED MONDAY (B)(6) 2014. THERAPY WAS NOT WORKING AS EXPECTED. THERE WAS A LOSS OF THERAPEUTIC EFFECT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURING REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-09986.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321619 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| O