BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3970764 · Received July 31, 2014

    Report

    Report Number
    3007566237-2014-02135
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 10, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-29, PRODUCT TYPE: ACCESSORY.. ADDITIONAL INFORMATION INDICATED THE CORRECT MANUFACTURING SITE ID WAS 9614453. ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR MODEL 37601 SN: (B)(4) FOUND THE DEVICE DID NOT MEET EXPECTED LONGEVITY. THE CAUSE WAS UNKNOWN. DATA GATHERED DURING THE REVIEW OF MANUFACTURING DATA, DIMENSIONAL INSPECTION, AND ELECTRICAL TESTING DID NOT SHOW ANY ABNORMAL RESULTS. THERE WAS NO EVIDENCE OF AN INTERNAL MECHANISM FOR PREMATURE DEPLETION DURING DESTRUCTIVE ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) PREMATURELY DEPLETED. IT WAS NOTED THE INS WAS REPLACED. IT WAS FURTHER NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. IT WAS NOTED THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CYCLING PROGRAMMED, THE REPORTER STATED THERE WAS PREMATURE DEPLETION BECAUSE THE 17 MONTH TIME OF LIVE FOR THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SHORTER THAN THE PREVIOUS INS WITH THE SAME SETTINGS WITH THE SAME PATIENT. IT WAS NOTED THAT A LONGEVITY CALCULATION WAS NOT DONE. IT WAS NOTED THE PATIENT WAS PROGRAMMED TO "B+ 1-, 3.0V, 90 MS, 135 HZ; B+ 5-, 2.4V, 90 MS, 135 HZ" IN (B)(6) 2013 AND "B+ 1-, 3.4V, 90 MS, 135 HZ; B+ 5-, 2.6V, 90 MS, 135 HZ" IN (B)(6) 2013. IT WAS FURTHER NOTED THE PATIENT WAS PROGRAMMED TO "B+ 1-, 3.4V, 90 MS, 135 HZ; B+ 5-, 2.2V, 90 MS, 135 HZ" IN (B)(6) 2014 AND "B+ 1-, 3.2V, 90 MS, 135 HZ; B+ 5-, 2.2V, 90 MS, 135 HZ" IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446720 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention