BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2874012 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11847
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    February 23, 2010
    Report Date
    June 29, 2018
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION DEVICE USED FOR WAS MRU. PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3387S-40, LOT# V371989, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMINANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V371989, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THERE WAS A MAJOR BLEED DUE TO AN ERROR IN PASSING THE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A MASSIVE STROKE TO HER BRAIN ON (B)(6) 2010 DURING DEEP BRAIN STIMULATION (DBS) SURGERY AND WENT INTO A COMA AFTERWARDS. IT WAS NOT DETERMINED IF THE STROKE DAMAGED THE AREA THAT WOULD HAVE HAD DYSTONIA IMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THIS EVENT HAD OCCURRED PRIOR TO WHEN THE PATIENT CAME TO THE CLINIC. AT THAT TIME THE PATIENT WAS WORKING WITH A DIFFERENT HEALTHCARE PROFESSIONAL (HCP). FULL NOTES FOR THAT EVENT WERE NOT BROUGHT TO THIS CLINIC. THE PATIENT FIRST CAME TO THE CURRENT CLINIC ON (B)(6) 2011. THE CURRENT HCP WAS NOT CERTAIN WHEN THE STROKE HAD HAPPENED BUT BELIEVED IT WAS DURING IMPLANT SURGERY. IT WAS STATED THAT IT WAS A CONFIRMED STROKE. A SUBDURAL HEMATOMA WAS ALSO REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER INDICATING THAT AS A RESULT OF THE STROKE SHE HAD DURING THE IMPLANT PROCEDURE, SHE NEVER NEEDED THE DBS THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization