BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2141197 · Received June 22, 2011

    Report

    Report Number
    3007566237-2011-04654
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    August 1, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: ATLI A, THEODORE BR, TURK DC, LOESER JD. INTRATHECAL OPIOID THERAPY FOR CHRONIC NONMALIGNANT PAIN: A RETROSPECTIVE COHORT STUDY WITH 3-YEAR FOLLOW-UP. PAIN MEDICINE. 2010;11(7):1010-1016. SUMMARY: THE AUTHORS PRESENT AN ANALYSIS OF OUTCOMES AFTER INTRATHECAL OPIOID TREATMENT BY PERFORMING A RETROSPECTIVE CHART REVIEW WITHIN A (B)(6) HOSPITAL AND CLINIC THAT HAD THEIR FIRST PUMP IMPLANTED BETWEEN (B)(6) 1999 AND (B)(6) 2003. A TOTAL OF 57 PATIENTS RECEIVED NEW INTRATHECAL CATHETERS AND PUMPS; THERE WERE 27 MALES AND 30 FEMALES. REPORTABLE EVENT: SEVEN PATIENTS DID NOT COMPLETE A 3-YEAR FOLLOW-UP: TWO HAD CANCER, ONE WHO WAS DIAGNOSED WITH CANCER AFTER HIS PUMP WAS IMPLANTED FOR ANOTHER DIAGNOSIS, RAPIDLY DETERIORATED FROM HIS MALIGNANT DISEASE, TWO PATIENTS HAD EARLY INFECTIONS AND MULTIPLE PUMP AND CATHETER REVISIONS RENDERING THE THERAPY IMPOSSIBLE TO EVALUATE, AND TWO WERE LOST TO FOLLOW-UP. ONE ADDITIONAL PATIENT WAS EXCLUDED FROM THE ANALYSIS OF PHARMACOLOGIC AND PAIN LEVEL OUTCOMES DUE TO EXCESSIVELY HIGH PREIMPLANTATION ORAL OPIOID INTAKE. FOURTEEN COMPLICATIONS OCCURRED IN 10 OF THE 57 PATIENTS; THESE INCLUDED 5 PATIENTS WITH INFECTIONS, 3 WITH CATHETER REVISIONS DUE TO CATHETER MIGRATION/FRACTURE, 2 WITH A SEROMA AT THE PUMP SITE, 2 WHO HAD A PUMP MALPOSITION, AND 2 WHO DEVELOPED AN INTRATHECAL GRANULOMA. BY THE END OF THE STUDY PERIOD, 10 PATIENTS HAD THEIR PUMPS AND CATHETERS REMOVED EITHER BECAUSE OF INFECTION OR LOSS OF EFFICACY AND 2 PATIENTS WERE NOT USING THEIR PUMPS ALTHOUGH THEY HAD NOT BEEN EXPLANTED. THE INFECTIONS WERE MANIFEST AT THE PUMP INSERTION SITE AND ARE THEREFORE NOT LIKELY TO BE DUE TO THE METHOD OF TRIALING INTRATHECAL DRUG ADMINISTRATION. NO PATIENT DEVELOPED MENINGITIS. WE ALSO ASSESSED THE SIDE EFFECTS OF INTRATHECAL OPIOID THERAPY OVER 3 YEARS. OF 54 PATIENTS FOR WHOM WE HAD DATA ON SIDE EFFECTS, 48 REPORTED NONE, 5 PATIENTS REPORTED SIGNIFICANT EDEMA, 1 HAD MYOCLONIC JERKING, 3 HAD URINARY RETENTION, AND 2 REPORTED NAUSEA AND VOMITING. THESE WERE THE ONLY REPORTED SIDE EFFECTS OF OPIOID THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IMPLANTABLE INFUSION PUMP: MODEL PUMP, LOT # UNK| IMPLANTED:| EXPLANTED: