BEUDAMED
    FDA Adverse Event Death Summary report: N

    CODMAN

    MDR report key: 17346176 · Received July 18, 2023

    Report

    Report Number
    3015537318-2023-00022
    Event Type
    Death
    Date Received
    July 18, 2023
    Date of Event
    January 1, 2016
    Report Date
    July 18, 2023
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERA ONCOLOGY ACQUIRED PMA P890055 FROM CODMAN & SHURTLEFF/CERENOVOUS IN 2020. INTERA ONCOLOGY DOES NOT MANUFACTURE THE 3000-16 LOW FLOW INFUSION PUMP. INTERA ONCOLOGY DOES NOT CURRENTLY MARKET DEVICES FOR BACLOFEN INFUSION. NO RECORD OF THIS COMPLAINT WAS LOCATED IN SEARCHING TRANSFERRED COMPLAINT RECORDS FROM THE PREVIOUS PMA HOLDER. EXACT DATE OF DEATH WAS NOT PROVIDED. BLANK INFORMATION IN THE MDR FORM REPRESENTS UNKNOWN INFORMATION. IF FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    PATIENT'S SPOUSE CALLED INTO THE CLINICAL CALL LINE IN RESPONSE TO A ROUTINE DEVICE TRACKING MAILER STATING THAT HER HUSBAND DIED IN 2016. SHE STATED "AS FAR AS SHE KNOWS HE DIED FROM COMPLICATIONS FROM THE PUMP WHICH SENT BACLOFEN TO HIS BRAIN. HE PASSED AT THE (B)(6)." IT WAS REPORTED THAT SHE 'DOES NOT KNOW THE STATUS OF THE PUMP.' THE DEVICE WAS A CODMAN 16 ML LOW FLOW PUMP, IMPLANT DATE WAS (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765833 CODMAN IMPLANTABLE DRUG DELIVERY PUMP LKK CODMAN & SHURTLEFF 3016-L

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death