BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3142718 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01834
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: UNK SERIAL/LOT#: UNK, (B)(4).

    Description of Event or Problem · 1

    KRETZSCHMAR, M., GRO, W., SEIDEL, J., PETERS, F., REMANE, D. ABSTRACTS FROM THE ANNUAL MEETING OF THE GERMAN SOCIETY OF NEUROMODULATION (DGNM) JOINT MEETING WITH THE NEUROMODULATION SOCIETY OF THE UNITED KINGDOM AND IRELAND (NSUKI). 23-24 NOVEMBER 2012, BERLIN, GERMANY. INTRATHECAL HYDROMORPHON AND PREGNANCY: CASE REPORT AND IMPLICATIONS FOR CLINICAL CARE. NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE. 2013;16(2):E5. SUMMARY: THE PATIENT WAS A (B)(6) WITH A HISTORY OF FAILED BACK SURGERY SYNDROME WHOSE INTRACTABLE PAIN HAS BEEN MANAGED WITH INTRATHECAL HYDROMORPHONE 1.2 MG PER DAY VIA AN IMPLANTED PUMP FOR 1.5 YEARS. THIS WAS THE THIRD PREGNANCY, THE PATIENT ALREADY HAS TWO CHILDREN (B)(6). THE PREGNANCY WAS UNEVENTFUL UP TO THE (B)(6) WEEK WITHOUT ANY PROBLEMS. AT THAT STAGE SHE DEVELOPED SHORT LIVED HYPERTENSIVE EPISODES FOR A FEW DAYS WHICH WERE WELL CONTROLLED BY ANTIHYPERTENSIVE DRUGS. FROM THE (B)(6) WEEK BACK PAIN INCREASED IN THE AREA OF PREVIOUS BACK SURGERY. AT (B)(6) A PRETERM NORMAL-TO-DATES INFANT (B)(6) WAS DELIVERED BY CAESAREAN SECTION (LSCS). BECAUSE OF RESPIRATORY DISTRESS THE CHILD WAS ADMITTED TO SPECIAL CARE BABY UNIT FOR 8 DAYS. THE CHILD WAS DISCHARGED HOME IN STABLE CONDITIONS. THE ANALYSIS OF UMBILICAL CORD BLOOD AND 24 HOUR-URINE SAMPLE OF THE NEWBORN CHILD FOR HYDROMORPHONE AND ITS METABOLITES SHOWED UNEQUIVOCAL RESULTS (PROOF BORDER: 0.5 PG/ML). THIS PAPER REVIEWS LITERATURE TO DATE AND PRESENTS THE PARTICULARITY OF OUR CASE. IT ALSO DISCUSSES MANAGEMENT OF PREGNANT PATIENTS WITH AN INTRATHECAL PUMP INCLUDING INFORMATION ABOUT SAFETY AND EFFICACY OF THIS TREATMENT. REPORTED EVENT: THIS FILE IS IN RELATION TO THE NEWBORN. AT (B)(6) A PRETERM NORMAL-TO-DATES INFANT (B)(6)WAS DELIVERED BY CAESAREAN SECTION (LSCS). BECAUSE OF RESPIRATORY DISTRESS THE CHILD WAS ADMITTED TO SPECIAL CARE BABY UNIT FOR 8 DAYS. THE CHILD WAS DISCHARGED HOME IN STABLE CONDITIONS. THE ANALYSIS OF UMBILICAL CORD BLOOD AND 24 HOUR-URINE SAMPLE OF THE NEWBORN CHILD FOR HYDROMORPHONE AND ITS METABOLITES SHOWED UNEQUIVOCAL RESULTS (PROOF BORDER: 0.5 PG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245056 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization