BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3200191 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11139
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 6, 2013
    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

    ANALYSIS OF THE EXTENSION MODEL 748240 SERIAL (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE EXTENSION WAS CUT THROUGH AND THE PRODUCT SEGMENTED. ANALYSIS OF THE ADAPTOR MODEL 64001 LOT UNKNOWN FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 64001, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ADAPTER; PRODUCT ID 3387-40, LOT# V002692, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4). 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

    IT WAS FURTHER REPORTED THAT A MANUFACTURE REPRESENTATIVE HAD JUST MET WITH THE PATIENT AND THE PATIENT WAS "DOING GREAT" WITH "NO PROBLEMS WHATSOEVER".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THE EXTENSION AND POCKET ADAPTOR WERE EXPLANTED. THE EXTENSION WAS REPLACED AND THE ADAPTER ¿WAS JUST BYPASSED ALTOGETHER.¿ IT WAS FURTHER NOTED THE PATIENT HAD A SHOCKING SENSATION AT THE POCKET SITE WHENEVER THE POCKET WAS PRESSED MANUALLY OR WITH THE RECHARGER. THE PATIENT FELT ¿A LITTLE SHOCK EVERY NOW AND THEN.¿ IT WAS NOTED THIS OCCURRED FOR FOUR DAYS PRIOR TO REPORT AND ONLY WITH STIMULATION. IT WAS NOTED THAT THE PATIENT THEN TURNED THE BATTERY OFF. IT WAS NOTED THAT THE PATIENT WAS SEEN BY A HEALTHCARE PROFESSIONAL (HCP) ONE DAY PRIOR TO REPORT. IT WAS FURTHER NOTED AN ASSESSMENT WAS CONDUCTED AND IT WAS ASSUMED THAT THERE WAS A BROKEN WIRE. IT WAS NOTED THAT ¿IMPEDANCE WISE IT WAS FINE ¿ BUT A LITTLE BIT HIGH.¿ THERE WERE NO OPEN CIRCUITS. OVERALL THE PATIENT WAS DOING FINE. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299061 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention