BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2892681 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00029
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 10, 2012
    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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE NEUROSTIMULATOR REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE BATTERY WAS AT ITS NORMAL END OF LIFE. FINAL DEVICE ANALYSIS OF THE PLUG AND CAP REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS DEPRESSION. PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID, 3550-09 LOT# N292519, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 3550-09 LOT# N272709, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N272113, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N177550, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N193799, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N272113, PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N193799, PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N292519, PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N272709, PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N250564, PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N133836, IMPLANTED: 2010 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# UNKNOWN, PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# UNKNOWN, PRODUCT TYPE ACCESSORY PRODUCT ID, 3391S-40 LOT# V159340, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3391S-40 LOT# V159340, PRODUCT TYPE LEAD. (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 REPORTED THERE WAS AN OVERDOSE AND SUICIDE ATTEMPT. IT WAS NOTED, PATIENT REPORTED INTENTIONALLY TAKING EXTRA MEDICATION WITH THOUGHT OF NOT CARING IF THEY DIED FROM DOING IT. SUICIDAL IDEATION AND RECENT OVERDOSE OF FIVE CLONAZEPAM, 0.5 MG TABS TOTAL OF 2.5 MG. IT WAS NOTED REPROGRAMMING WAS DONE ON (B)(6) 2012 AND THERE WAS A SCHEDULED BATTERY REPLACEMENT ON (B)(6) 2012. ADDITIONAL INFORMATION REPORTED, THE PATIENT RESOLVED WITHOUT SEQUELA. THERE WAS INCREASED VIGILANCE AS NEW INTERVENTION. IT WAS ALSO NOTED, THE PATIENT HAD PRE-EXISTING CONDITION OF DEPRESSION, WORSENING OR EXACERBATION. IT WAS REPORTED BOTH IMPLANTABLE NEUROSTIMULATORS (INS) WERE REPLACED DUE TO NORMAL BATTERY DEPLETION. PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Life Threatening| O