BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3796324 · Received May 7, 2014

    Report

    Report Number
    3004209178-2014-08633
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    April 17, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387S-40, LOT# V011138, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V011138, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT # V011138, IMPLANTED: (B)(4) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V011138, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; 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 WAS NOT ABLE TO USE THEIR HANDS. IT WAS NOTED, THE PATIENT HAD PAIN, TINGLING, AND NUMBNESS IN THEIR HANDS. IT WAS STATED, THEY HAD NO MOBILITY IN THEIR LEFT HAND AND THE LEFT HAND WAS WORSE THAN THE RIGHT. IT WAS NOTED, THE CONDITION HAD GOTTEN PROGRESSIVELY WORSE SINCE (B)(6) 2013. IT WAS STATED THEY WERE UNSURE IF THE DEEP BRAIN STIMULATOR (DBS) STILL WORKED AS IT HAD BEEN 4 YEARS SINCE THEIR LAST BATTERY CHANGE. IT WAS NOTED THEY CORTISONE IN THEIR LEFT HAND AT ONE TIME BUT IT DID NOT HELP. IT WAS NOTED, THE PATIENT¿S CONDITION ¿MAY NOT BE DUE TO THE INSTRUMENT ITSELF.¿ IT WAS FURTHER REPORTED, THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED, THE PATIENT HAD FALLEN MORE THAN USUAL. IT WAS STATED IN (B)(6) 2013, THE PATIENT HAD STARTED TO FALL A LOT BUT THAT WAS BECAUSE THEY WEREN¿T TAKING ONE OF THEIR MEDICATIONS. IT WAS STATED WHEN THE PATIENT GOT BACK ON THE MEDICATION THEIR WALKING GOT BETTER BUT IN THE LAST FEW WEEKS OR MONTHS PRIOR TO REPORT THE PATIENT¿S WALKING HAD GOTTEN WORSE. IT WAS NOTED, THE PATIENT HAD A MAGNETIC RESONANCE IMAGE (MRI) PERFORMED ON ONE OF THEIR ARMS A COUPLE OF MONTHS PRIOR TO REPORT. IT WAS FURTHER REPORTED, THE PATIENT HAD A SURGERY THE DAY PRIOR TO REPORT TO REPLACE THEIR BATTERIES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SEEN ON (B)(6) 2014 DUE TO FREEZING EPISODES. PATIENT HAD BEEN DOING WELL SINCE PLACEMENT IN 2010 BUT OVER THE PAST FEW WEEKS PRIOR TO THE DATE OF THIS REPORT THE PATIENT HAD NOTICED THAT HE HAD SEVERAL EPISODES OF FREEZING AND FALLING SECONDARILY. PATIENT ALSO HAD DETERIORATION OF HIS GENERAL CONDITION. THE PATIENT HAD PROBLEMS WITH LIMB COORDINATION. THE PATIENT WAS IN A WHEELCHAIR, HAD CRAMPING OF THE LEFT HAND, SIGNIFICANT RIGIDITY IN ALL EXTREMITIES AND DECREASED COORDINATION WITH ALTERNATING MOVEMENTS. IT WAS NOTED THAT BOTH IMPLANTABLE NEUROSTIMULATORS (INS) WERE INTERROGATED AND SHOWED DECREASED VOLTAGES. IT WAS NOTED THAT THE IMPRESSION WAS BILATERALLY FAILING INSS. REPLACEMENT OF THE 2 DEVICES WAS DISCUSSED AND PATIENT WAS GOING TO PROCEED WITH SURGERY. PATIENT WAS HAVING PAIN AT A SCORE OF 8 IN THE RIGHT AND LEFT HAND FOR THE PAST 9 MONTHS PRIOR TO THE VISIT ON (B)(6) 2014. THE PATIENT HAD TINGLING AND NUMBNESS. ON (B)(6) 2014, IT WAS NOTED THAT THE DEVICE COULD NOT BE TURNED OFF. THE PATIENT HAD AN ELECTROCARDIOGRAM SCAN. ON (B)(6) 2014, PATIENT¿S PRE-OPERATIVE STATUS WAS PARKINSON¿S DISEASE WITH BILATERAL FAILING DEVICES. POST-OPERATIVE WAS UNCHANGED. DEVICES WERE REPLACED AND IMPEDANCES WERE ADEQUATE. THE PATIENT HAD RETURNED TO THE RECOVERY ROOM WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275904 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention