BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 9332193 · Received November 15, 2019

    Report

    Report Number
    3004209178-2019-21941
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    October 23, 2019
    Report Date
    February 25, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000175719
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT#: VA01MBS, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT#: V992702, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. PRODUCT ID: 3708695, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708695, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 09-DEC-2014, UDI#: (B)(4). PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 16-NOV-2014, UDI#: (B)(4). PRODUCT ID: 3708695, SERIAL/LOT #: (B)(4), UBD: 22-NOV-2020, UDI#: (B)(4). PRODUCT ID: 3708695, SERIAL/LOT #: (B)(4), UBD: 22-NOV-2020, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 THAT OVER THE THREE DAYS PRIOR TO THIS REPORT, THE PATIENT DEVELOPED PAIN, REDNESS, AND SWELLING TO THE LEFT ANTERIOR NECK TO THE BACK OF THEIR HEAD AND FELT THE LEAD WAS INFECTED. THE CLINICAL DIAGNOSIS WAS INFECTION AND DEVICE DIAGNOSIS WAS EROSION THROUGH THE SKIN. DIAGNOSTICS INCLUDED PATIENT REPORT OF INFECTION AND EXAMINATION WHICH FOUND CELLULITIS. INTERVENTIONS INCLUDED EMERGENCY ROOM VISIT, EXPLANT OF THE ENTIRE SYSTEM WITHOUT REPLACEMENT, AND HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION. THE DEVICES WERE DISPOSED ACCORDING TO BIOHAZARD INSTRUCTIONS. THE EVENT WAS CONSIDERED RELATED TO DEVICE/THERAPY, NOT RELATED TO PROCEDURE, AND RELATED TO BURR HOLE SITE. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2019. THE PATIENT WAS IMPLANTED FOR PARKINSON'S DUAL AND DBS THERAPY INDICATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM AN HCP OF A CLINICAL STUDY INDICATED THE INFECTION WAS IDENTIFIED AS PSEUDOMONAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122889 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00763000175719

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R