BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4122951 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17835
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# VA02PXP, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# VA02PXP, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE EXTENSION (S/N (B)(4)) FOUND THE DISTAL END CONDUCTOR WAS BROKEN UP TO THE TRANSITION POINT.

    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.

    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 REPORTED THE ELECTRODE IMPEDANCES WERE HIGH ON CONTACT 8<(>&<)>9 AT 12,472 OHMS, CONTACT 8<(>&<)>10 AT 6,349 OHMS, CONTACT 8<(>&<)>11 AT 7,624 OHMS AND CONTACT 9<(>&<)>11 AT 5,353 OHMS. THERE WERE NO COMPLICATIONS AND THE EXTENSION WAS REPLACED. ALL ELECTRODE IMPEDANCES WERE WITHIN NORMAL LIMITS WITH THE NEW EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS HIGH IMPEDANCE ON THE EXTENSION. THE IMPEDANCES READ: 8 <(>&<)>9-12472 OHMS, 8 <(>&<)> 10-6349 OHMS, 8 <(>&<)> 11-7624 OHMS, 9 <(>&<)> 11-5353 OHMS, C <(>&<)> 8-7460 OHMS, AND C <(>&<)> 9-4275 OHMS. A REPLACEMENT WAS REQUIRED AS A RESULT. THERE WAS A DAMAGED EXTENSION WHICH CAUSED THE HIGH IMPEDANCES. THE RIGHT LEAD IMPEDANCES WERE TESTED INTRA-OPERATIVELY WITH AN EXTERNAL NEUROSTIMULATOR (ENS) AND ALLIGATOR CLIPS. ALL THE IMPEDANCES WERE NORMAL WITHIN THE LEAD. ONCE A NEW EXTENSION WAS IMPLANTED ALL OF THE IMPEDANCES WERE WITHIN NORMAL RANGE WHEN CHECKED IN POCKET. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY AND NO PATIENT SYMPTOMS WERE REPORTED. AS A RESULT OF THE HIGH IMPEDANCES, THE NEUROLOGIST HAD TO PROGRAM AROUND THE HIGH IMPEDANCES USING CASE AND 10. THEY FELT HE HAD BETTER CONTROL OF HIS SYMPTOMS WHEN CONTACTS 8 AND 9 WERE USED. NO OUTCOME WAS 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
    600526 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention