BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6166190 · Received December 12, 2016

    Report

    Report Number
    3004209178-2016-26214
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    November 18, 2016
    Report Date
    February 8, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS 37602 ACTIVA SC NEUROSTIMULATOR S/N (B)(4) FOUND THE INS TO BE FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A REP. IT TURNED OUT THAT NO ACTUAL POCKET ZAPPING OCCURRED. INSTEAD, IT WAS ONLY THAT MANIPULATION OF THE RIGHT INS IN THE POCKET CAUSED CONTRALATERAL PARESTHESIAS ON THE LEFT SIDE OF THE BODY. THE CAUSE WAS NEVER DETERMINED BECAUSE THE REP WAS TOLD THAT THE IMPEDANCES CHECKED OUT NORMALLY, EVEN WHEN TESTED IN THE POSITION THAT CAUSED THE PARESTHESIAS. THE NEUROLOGIST GAVE THE PATIENT A NEW ELECTRODE CONFIGURATION TO TRY, BUT THE PARESTHESIAS PERSISTED. THE NEUROLOGIST AND THE SURGEON DECIDED TO REPLACE THE INS ON (B)(6) 2016. IT WAS UNKNOWN IF THE NEW INS RESOLVED THE PARESTHESIAS.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT MANIPULATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) IN THE PATIENT¿S RIGHT CHEST POCKET CAUSED REPRODUCIBLE LEFT BODY PARESTHESIAS AND POCKET ZAPPING. THE RECENT BATTERY REPLACEMENT AND RELATED SWELLING OR FLUID IN THE POCKET COULD HAVE CONTRIBUTED TO THE CURRENT SPREAD. THE NEUROLOGIST PERFORMED AN ELECTRODE IMPEDANCE TEST TO DETERMINE IF THERE WERE CONNECTIONS ISSUES, BUT THE SYSTEM CHECKED OUT INTACT AND NORMAL. THE IMPEDANCES CHECKED OUT NORMAL EVEN DURING THE PARESTHESIA INDUCED MANIPULATION. IT WAS DIFFICULT TO DIAGNOSE THE ROOT CAUSE OF THE ISSUE, BUT IT WAS REPRODUCIBLE. THE NEUROLOGIST TRIED A DIFFERENT BIPOLAR SETTING AND WOULD CHECK BACK WITH THE PATIENT AT FOLLOW-UP TO ASK IF THE PARESTHESIAS RESOLVED. NO SURGICAL INTERVENTION WAS TAKEN OR PLANNED. THE PATIENT¿S INDICATION(S) FOR USE WERE ESSENTIAL TREMOR AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817867 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention