BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2230764 · Received August 23, 2011

    Report

    Report Number
    6000030-2011-06714
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    October 16, 2009
    Report Date
    October 5, 2017
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SYMPTOMS OF WITHDRAWAL WERE REPORTED. IT WAS STATED THAT THERE WAS A LARGE AMOUNT OF ASPIRATED DRUG VOLUME DURING PUMP REFILL. BATTERY DEPLETION WAS ALSO STATED. THE PUMP WAS REPLACED. PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THE PATIENT HAD SYMPTOMS OF WITHDRAWAL. THE DEVICE EVENT WAS NOTED AS BATTERY DEPLETION. IT WAS NOTED THERE WAS A LARGE AMOUNT OF ASPIRATED DRUG VOLUME WITH THE PUMP REFILL. NO DIAGNOSTIC METHODS WERE LISTED. THE DEVICE WAS REPLACED ON (B)(6) 2009. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2009. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY INDICATED THERE WERE NO SYMPTOMS OF WITHDRAWAL. THE PATIENT HAD INADEQUATE PAIN CONTROL WITHOUT SYMPTOMS OF WITHDRAWAL. IT WAS NOTED THERE WAS 3.7ML OF THE EXPECTED RESIDUAL VOLUME AND 16.6ML OF ACTUAL RESIDUAL VOLUME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY INDICATED THE CAUSE OF THE VOLUME DISCREPANCY WAS NOT DETERMINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY REPORTED PER PRIVATE INVESTIGATOR THE BATTERY DEPLETION WAS PREMATURE WITH NO CAUSE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention CATHETER: MODEL 8731, LOT# B008852N30| IMPLANTED:| EXPLANTED: