BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2915740 · Received January 15, 2013

    Report

    Report Number
    3004209178-2013-00594
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Report Date
    December 21, 2012
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 748251, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION; PRODUCT ID: 748251, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387-40, LOT#: J0118279V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD; PRODUCT ID: 3387-40, LOT#: J0118279V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW REPORTED THAT THE PATIENT WAS ¿NEVER FULLY HAPPY¿ WITH THE THERAPY. THE LEFT SIDE OF HIS BODY WAS THE SIDE THAT WAS HAVING A PROBLEM. THE LEFT SIDE HAD ¿NEVER BEEN AS GOOD AS THE OTHER SIDE.¿

    Description of Event or Problem · 1

    ABNORMAL IMPEDANCE VALUES WERE REPORTED. IMPEDANCE VALUES AND CURRENTS ON UNIPOLAR PAIRS WERE AS FOLLOWS: C-0: 1217 OHMS, 13 MA C-1: >2000 OHMS, 10 MA C-2: >2000 OHMS, 10 MA C-3: 1245 OHMS, 13 MA 0-1: >2000 OHMS, 9 MA 0-2: >2000 OHMS, 9 MA 0-3: 111 OHMS, 70 MA 1-2: >2000 OHMS, 8 MA 1-3: >2000 OHMS, 8 MA 2-3: >2000 OHMS, 9 MA. IT WAS STATED THAT THE PATIENT HAD "SOME IMPEDANCE ISSUES IN THE DISTANT PAST" AND NOTHING HAD TO BE DONE ABOUT THAT, "THEY JUST KIND OF HAD GONE AWAY." IT WAS MENTIONED THAT X-RAY ASSESSMENT HAD BEEN PERFORMED. IMPEDANCE VALUES ON "THE OTHER SIDE LOOKED PRETTY GOOD." THE THERAPY IMPEDANCE THERE WAS 1231 OHMS WITH A CURRENT OF 43 MA. IT WAS STATED THAT THE LEFT SIDE OF HIS BODY WAS THE SIDE THAT WAS HAVING A PROBLEM. THE PATIENT HAD REPROGRAMMING DONE A COUPLE DAYS PRIOR TO THE REPORT AND AT THE TIME OF THE REPORT THE THERAPY WAS "NOT AS GOOD." THE DOCTOR WOULD TRY REPROGRAMMING AGAIN TO RECOVER THERAPY. IMPEDANCES WERE REPORTED AS FINE AT THE TIME OF THE REPROGRAMMING SESSION. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPROGRAMMED "A BIT." "THE CASE POSITIVE" WAS CHANGED TO "A NEGATIVE" AND "WITH THE SAME PULSE RATE." THE PATIENT CAME INTO THE OFFICE AT 3 VOLTS, BUT WAS UNABLE TO "GET UP PAST 0.8 VOLTS" AFTER REPROGRAMMING. WHEN THE VOLTAGE WAS INCREASED PAST 0.8 V, THE PATIENT "WAS GETTING DYSTONIA." IT WAS STATED THAT THE PATIENT WAS NOT DOING WELL. CURRENT IMPEDANCES WERE "MUCH HIGHER THAN THEY WERE AT THE START." IT WAS SUSPECTED THAT "SOMETHING HAD CHANGED WHILE THE PATIENT HAD BEEN BEING PROGRAMMED." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22358 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1