BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3951514 · Received July 23, 2014

    Report

    Report Number
    3007566237-2014-02042
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    GHOBRIAL, G.M., THAKKAR, V., SINGHAL, S., OPPENLANDER, M.E., MAULUCCI, C.M., HARROP, J.S., JALLO, J., PRASAD, S., SAULINO, M., SHARAN, A.D. EFFICACY OF INTRAOPERATIVE VANCOMYCIN POWDER USE IN INTRATHECAL BACLOFEN PUMP IMPLANTATION PROCEDURES: SINGLE INSTITUTIONAL SERIES IN A HIGH RISK POPULATION. JOURNAL OF CLINICAL NEUROSCIENCE. 2014. DOI: 10.1016/J.JOCN.2014.04.007. SUMMARY: WE AIMED TO ASSESS THE EFFICACY OF INTRAOPERATIVE VANCOMYCIN POWDER IN INTRATHECAL BACLOFEN PUMP PLACEMENT PATIENTS, A HIGH RISK POPULATION. A RETROSPECTIVE REVIEW WAS CONDUCTED USING PROSPECTIVELY COLLECTED DATA AT AN ACADEMIC TERTIARY CARE UNIT. THE NEUROSURGICAL ADULT PATIENT POPULATION WAS QUERIED FOR ALL INTRATHECAL BACLOFEN PUMP IMPLANTATION PROCEDURES. PATIENTS WERE THEN REVIEWED FOR THE USE OF INTRAOPERATIVE CRYSTALLINE VANCOMYCIN POWDER. THOSE WITH A HISTORY OF PRIOR SURGICAL SITE INFECTION, CHRONIC SYSTEMIC INFECTIONS OR OSTEOMYELITIS WERE EXCLUDED. ANHYDROUS, CRYSTALLINE VANCOMYCIN WAS UTILIZED IN THE WOUND BED AFTER COMPLETION OF IMPLANTATION, DISTRIBUTED EVENLY IN THE CASE OF MULTIPLE INCISIONS. PATIENTS RECEIVED 500 MG OR 1000 MG OF CRYSTALLIZED VANCOMYCIN, EVENLY DISTRIBUTED THROUGH THE WOUND LAYERS BASED ON A 70 KG WEIGHT CUTOFF. INTRAOPERATIVE INSTITUTIONAL STANDARDS OF INFECTION PROPHYLAXIS WERE UNCHANGED THROUGHOUT THE STUDY PERIOD. INFECTION RATE OF BACLOFEN PUMP PLACEMENT PRIOR TO THE USE OF VANCOMYCIN POWDER FROM 2001¿2009 AT THE SAME INSTITUTION WAS MONITORED. WOUND INFECTION RATE WAS TRACKED FOR A 12 MONTH POSTOPERATIVE PERIOD. SIX PATIENTS OUT OF 26 BACLOFEN PUMP IMPLANTATIONS (23%) IN THIS COHORT WERE IDENTIFIED TO HAVE SEVEN INFECTIONS DESPITE VANCOMYCIN POWDER PLACEMENT IN THE LUMBAR AND CATHETER WOUNDS. PRIOR INFECTION RATES HAVE BEEN INVESTIGATED FOR INTRATHECAL DRUG DELIVERY SYSTEMS FROM 2001 TO 2009 AT THE SAME INSTITUTION WITH AN OVERALL INFECTION RATE OF 3% (8/274). THE USE OF VANCOMYCIN POWDER IN PATIENTS WITH IMPLANTS IN THIS SERIES DID NOT REDUCE INFECTION RATES COMPARED TO PUBLISHED HISTORICAL CONTROLS, AND WAS ELEVATED COMPARED TO INSTITUTIONAL CONTROLS. FURTHER PROSPECTIVE STUDY OF THIS HIGH RISK PATIENT POPULATION IS WARRANTED. REPORTED EVENT: THE (B)(6) FEMALE DEVELOPED A SURGICAL SITE INFECTION OF THE PUMP RESULTING IN REMOVAL OF THE PUMP AND CATHETER. E. COLI WAS CULTURED. THIS PATIENT HAD 1 PRIOR PUMP SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431173 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention