BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1920152 · Received December 8, 2010

    Report

    Report Number
    3004209178-2010-10332
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    April 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (URINARY PROBLEMS-UNSPECIFIED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD DECENT PAIN RELIEF WITH 40%-50% REDUCTION IN HIS PAIN DURING HIS PUMP TRIAL. HOWEVER, ONCE THE PERMANENT PUMP WAS IMPLANTED, HIS PAIN RELIEF DIMINISHED AND HE STARTED HAVING SIDE EFFECTS. THE PT DEVELOPED URINARY PROBLEMS AND INCREASED WEAKNESS. AT THAT TIME, THE PA HAD MORPHINE, MARCAINE AND COMPOUNDED BACLOFEN IN THE PUMP. HOWEVER, THE PT RESPONDED BADLY TO THE COMPOUNDED BACLOFEN. THE PHYSICIAN THOUGHT THAT THE URINARY ISSUE DEVELOPED AS A RESULT OF THE BACLOFEN. THE COMPOUNDED BACLOFEN WAS REPLACED WITH FENTANYL, BUPIVICAINE AND CLONIDINE ALONG WITH THE MORPHINE AND MARCAINE. THE PT'S PAIN WORSENED, SO THE PHYSICIAN INCREASED THE MEDICATION DOSAGES IN TANDEM. EVENTUALLY, THE PT WAS RECEIVING FENTANYL AT 450 MCG/DAY, AT WHICH POINT, THE MARCAINE WAS REMOVED FROM THE PUMP. DUE TO THE FACT THAT THE PT WAS NOT RECEIVING THE DESIRED EFFECT AND HAD THE SIDE EFFECTS, THE DECISION WAS MADE TO REMOVE THE DEVICE. BY (B)(6) 2009, THE DECISION WAS MADE TO REMOVE THE PUMP ALTOGETHER. THE DOCTOR STARTED GRADUALLY WEANING THE PT OFF THE DRUGS. THE MEDICATION IN THE PUMP FINALLY REACHED 0.0 MG/DAY IN (B)(6) 2009 AND THE PUMP WAS REMOVED IN EARLY (B)(6) 2009. ACCORDING TO THE PHYSICIAN, THE PUMP WAS NOT THE ISSUE; THE ISSUE WAS THE PT'S INTOLERANCE TO THE MEDICATION. THE DATES OF DEVICE EXPLANT ARE UNCLEAR. ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION WITH THE PHYSICIAN BUT HAVE BEEN UNSUCCESSFUL THUS FAR. THE PT HAS NOT BEEN HEARD FROM BY THIS HCP IN SEVERAL MONTHS, BUT IT WAS BELIEVED THAT THE PT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N163094013| EXPLANTED:| IMPLANTED: