BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8272216 · Received January 23, 2019

    Report

    Report Number
    3004209178-2019-01588
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169105492
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS MDR SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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 RECEIVED FROM THE CLINICAL SITE VIA A REP INCLUDED ADDITIONAL IMPEDANCE INFORMATION. IMPEDANCE INFORMATION AT 0.7 AMPLITUDE: C <(>&<)> 10 2179 C <(>&<)> 11 2282 C <(>&<)> 0 1981 C <(>&<)> 1 1219 C <(>&<)> 2 1655 C <(>&<)> 3 2009 C <(>&<)> 8 2454 C <(>&<)> 9 2395 C <(>&<)> 10 2179 C <(>&<)> 11 2282 0 <(>&<)> 1 2038 0 <(>&<)> 2 2979 0 <(>&<)> 3 3652 1 <(>&<)> 2 1867 1 <(>&<)> 3 2549 2 <(>&<)> 3 2320 10 <(>&<)> 11 3835 ***MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT. ***

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) OF A CLINICAL STUDY VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD HIGH BIOPOLAR IMPEDANCES. THERE WERE NO KNOWN INTERVENTIONS AND THE EVENT WAS CONSIDERED ONGOING. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IMPEDANCE INFORMATION AT 0.7 AMPLITUDE: 8 & 10 4414, OHMS 8 &11 4579, OHMS 8 & 9 4579, OHMS 9 & 10 4105, OHMS 9 & 11 4440, OHMS C & 10 2179, OHMS C &11 2282 OHMS, C & 3 2009, OHMS C & 8 2454, OHMS C & 9 2395 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63176 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169105492

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR