BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7995689 · Received October 23, 2018

    Report

    Report Number
    3004209178-2018-23692
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    August 1, 2018
    Report Date
    October 23, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    B5: EVENT DESCRIPTION WAS CORRECTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2018, PRODUCT TYPE EXTENSION. PRODUCT ID 3389S-40, LOT# VA0JFXW, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2018, PRODUCT TYPE LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4)V, UBD: 02-SEP-2018, UDI#: (B)(4); PRODUCT ID: 3389S-40, SERIAL/LOT #: (B)(4), UBD: 11-MAR-2017, UDI#: (B)(4). DATE OF EVENT IS AN APPROXIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT CAME IN FOR A ROUTINE FOLLOW-UP AND THE PHYSICIAN NOTED A TIC ATTACHED TO THE PATIENT DIRECTLY OVER HIS GENERATOR. THE TIC BITE MORE THAN LIKELY CAUSED THE INFECTION OF THE DEVICE. DIAGNOSTICS/TROUBLESHOOTING INCLUDED REMOVING THE TIC BY THE PHYSICIAN AND THE AREA WAS CLEANED WITH ALCOHOL. THE ISSUE IS NOT RESOLVED AS THE PATIENT HAS A RETURN OF TREMORS AS RESULT OF EXPLANTATION. THE ENTIRE SYSTEM WAS EXPLANTED AND WERE DISCARDED BY THE CUSTOMER. THE HEALTHCARE PROVIDER HAS INCREASED HIS PARKINSON'S MEDICATIONS TO TRY AND HELP THE TREMORS UNTIL THE INFECTION IS CLEARED AND THE DEVICE CAN BE REIMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT CAME IN FOR A ROUTINE FOLLOW-UP AND THE PHYSICIAN NOTED A TIC ATTACHED TO THE PATIENT DIRECTLY OVER HIS GENERATOR. THE TIC BITE MORE THAN LIKELY CAUSED THE INFECTION OF THE DEVICE. DIAGNOSTICS/TROUBLESHOOTING INCLUDED REMOVING THE TIC BY THE PHYSICIAN AND THE AREA WAS CLEANED WITH ALCOHOL. THE ISSUE IS NOT RESOLVED AS THE PATIENT HAS A RETURN OF TREMORS AS RESULT OF EXPLANTATION. THE ENTIRE SYSTEM WAS EXPLANTED AND WERE DISCARDED BY THE CUSTOMER. THE HEALTHCARE PROVIDER HAS INCREASED HIS PARKINSON'S MEDICATIONS TO TRY AND HELP THE TREMORS UNTIL THE INFECTION IS CLEARED AND THE DEVICE CAN BE REIMPLANTED. NO OUT OF BOX FAILURE WAS REPORTED. NO SYMPTOMS WERE REPORTED. A REPLACEMENT WAS SENT TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834440 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention