BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3900374 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12203
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    October 13, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V550216, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V525542, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR P. THE MAIN COMPONENT OF THE SYSTEM, OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V550216, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V525542, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014 THE PATIENT¿S LEFT IMPLANTABLE NEUROSTIMULATOR (INS) SITE WAS SORE ¿ON TOP OF THE MUSCLE.¿ PATIENT WAS UNSURE IF IT WAS BECAUSE SHE HAD BEEN NEGLECTING THE PORT. IT WAS NOTED THAT IT HAD ONLY BEEN SORE FOR THE PAST 3 DAYS PRIOR TO THE DATE OF THIS REPORT SINCE SHE HAD GONE TO (B)(6). (B)(6) ¿HAD SO MUCH ENERGY THAT IT DEPLETED¿OK SOMETHING IN THE STADIUM HAD ACTIVATED THE STIMULATOR.¿ IT WAS LATER REPORTED THAT THE PATIENT STATED THAT THE ISSUE AT THE BASEBALL DOME HAD OCCURRED ON (B)(6) 2014. THE BASEBALL GAME WAS AT A HUGE DOME AND THE DOME OPENED ELECTRONICALLY. IT WAS NOTED THAT WHEN THE DOME OPENED THE PATIENT¿S MUSCLES STARTED TO CONTRACT WITHIN A 25 MINUTE PERIOD WHICH HAD COME ON SUDDENLY. THE DOME WAS MAGNETIC WHEN IT OPENED AND CLOSED. THE PATIENT¿S STIMULATOR WAS TURNED ON WHEN THE ISSUE HAD HAPPENED. PATIENT TOOK ADIVAN AND COGENTIN ORAL MEDICATION AND THAT HAD HELPED WITH THE MUSCLE CONTRACTIONS. ABOUT 6 MONTHS PRIOR TO THE DATE OF THIS REPORT THE PATIENT¿S BREAST NEAR THE IMPLANT HAD STARTED TO GET HARD. IT WAS NOTED THAT IT WAS UNKNOWN IF THIS HAD COME ON GRADUALLY OR SUDDENLY. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-12202.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS ALSO REPORTED THAT THE PATIENT'S "HAND CURLS WHEN THE SUPERDOME OPENS"; IT IS UNKNOWN WHEN THIS ISSUE BEGAN OCCURRING. THE PATIENTS MEDICAL HISTORY INCLUDED ALLERGIES TO DYES IN MEDICATION, SPINAL INJECTIONS OF BACLOFEN, ATIVAN, PROGENTIN, AND BENADRYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376971 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR