BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6557374 · Received May 10, 2017

    Report

    Report Number
    3007566237-2017-01802
    Event Type
    Injury
    Date Received
    May 10, 2017
    Report Date
    August 8, 2017
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3387S-40, LOT# V853898, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4) NO LONGER APPLIES TO THE EVENT AND HAS BEEN REMOVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT VIA THE MANUFACTURER REPRESENTATIVE (REP), REPORTING THAT THE PATIENT THOUGHT T HE BREAK IN THE LEAD WAS CAUSED BY THE INS MOVING TOO MUCH IN THE POCKET. THE PATIENT REPORTED THAT THIS WAS AN ISSUE SINCE (B)(6) 2016 DUE TO THE BATTERY PACK MOVING. THE REP REPORTED THAT THE ELECTRODE IMPEDANCES RUN AT 0.7V WERE: CASE <(>&<)> (B)(4) CASE <(>&<)> (B)(4) CASE <(>&<)> (B)(4) CASE <(>&<)> (B)(4) <(>&<)>(B)(4) <(>&<)> (B)(4) <(>&<)> (B)(4)<(>&<)> (B)(4) <(>&<)> (B)(4) <(>&<)> (B)(4) AND THE IMPEDANCES RUN AT 3.0V WERE: CASE <(>&<)> (B)(4) CASE <(>&<)> (B)(4) CASE <(>&<)> (B)(4) CASE <(>&<)> (B)(4) <(>&<)> (B)(4) <(>&<)> (B)(4) <(>&<)> (B)(4) <(>&<)> (B)(4) <(>&<)> (B)(4) <(>&<)> 3 2084 NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    (B)(4): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS). THE REP REPORTED THAT AT THE PATIENT'S SCHEDULED INS REPLACEMENT ON (B)(6) 2017, IT WAS NOTED THAT THE PATIENT'S LEAD WAS BROKEN. THE REP REPORTED THAT THE BREAK WAS CONFIRMED WITH AN X-RAY, SHOWING THE BREAK JUST ABOVE THE LEAD/EXTENSION CONNECTOR. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTING THAT THE PATIENT'S INS WAS WELL SECURED IN THE RIGHT UPPER CHEST WITH A PROLENE SUTURE, AND THAT THERE WAS NOT EVIDENCE OF MOVEMENT IN THE INS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338919 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention