BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 4242583 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21287
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 20, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V476623, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿YEARS AGO¿ THE PATIENT HAD AN MRI AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF, BUT THEIR HAND DID NOT SHAKE. THE PATIENT HAD THE INS ON, BUT THEY SAW NO DIFFERENCE IN THEIR SYMPTOMS. SEVEN YEARS AGO THE PATIENT WAS WALKING, BUT THEY DO NOT WALK ANYMORE. THE PATIENT HAD NOT SEEN THEIR HEALTHCARE PROFESSIONAL (HCP) FOR THREE YEARS TO HAVE THE DEVICE CHECKED. THE PATIENT COULD STILL DRINK OUT OF A WATER BOTTLE AND THEIR WRITING WAS THE SAME AS IT WAS PRIOR TO HAVING THE INS. THE PATIENT WANTED TO KNOW WHY THEY HAD THE DEVICE IF IT WAS NOT GOING THEM ANY GOOD AND THEY COULD NOT HAVE MRIS OF THEIR SPINE AND ANKLE. THREE YEARS PRIOR TO THIS REPORT, THEY WANTED TO CONFIRM IF THE ¿PROBE¿ WAS IN THE RIGHT PLACE. THE PATIENT DID NOT WANT TO HAVE ANOTHER SURGERY AND THEY DID NOT WANT THEIR ¿BRAIN SCRAMBLED.¿ THE PATIENT FURTHER STATED THAT IF THEY HAD BEEN TOLD ABOUT THE RESTRICTIONS AND NOT BEING ABLE TO HAVE MRIS OF THEIR SPINE AND ¿BROKE/CHIPPED¿ ANKLE, THEY WOULD NOT HAVE HAD THE IMPLANT IN THE FIRST PLACE. FOLLOW UP WITH THE PATIENT INDICATED THEY HAD AN APPOINTMENT WITH THEIR HCP TO HAVE THE SYSTEM CHECKED. THE PATIENT WAS UNSURE IF THE SYSTEM WAS WORKING AND THEY HAD A LACK OF EFFECT WITH THE SYSTEM. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726112 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR