BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2910962 · Received January 11, 2013

    Report

    Report Number
    3007566237-2013-00118
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    September 6, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    HESTER, S. M., FISHER, J. F., LEE, M. R., MACOMSON, S., VENDER, J. R. EVALUATION OF SALVAGE TECHNIQUES FOR INFECTED BACLOFEN PUMPS IN PEDIATRIC PATIENTS WITH CEREBRAL PALSY. JOURNAL OF NEUROSURGERY. PEDIATRICS. 2012;10(6):548-554. DOI: 10.3171/2012.9.PEDS12121. SUMMARY: THE AUTHORS REVIEWED THE RECORDS OF 207 PATIENTS RANGING FROM 3 TO 18 YEARS OF AGE WITH CEREBRAL PALSY WHO UNDERWENT PLACEMENT OR REVISION OF A BACLOFEN PUMP. THEY IDENTIFIED 38 PATIENTS WITH SUSPECTED OR DOCUMENTED INFECTIOUS COMPLICATIONS. INITIAL ATTEMPTS WERE MADE TO ERADICATE INFECTION WITH THE DEVICES IN SITU IN ALL PATIENTS. METHODS AND EFFECTIVENESS OF PUMP SALVAGE WERE EVALUATED. OF THE 38 PATIENTS IDENTIFIED, 13 (34.2%) HAD DOCUMENTED INFECTIONS; 11 HAD DEEP WOUND/POCKET EMPYEMAS AND 2 HAD MENINGITIS. EIGHT PATIENTS WITH DEEP WOUND INFECTIONS RECEIVED INTRAVENOUS ANTIBIOTICS ALONE. ALL REQUIRED PUMP EXPLANTATION. THE REMAINING 3 PATIENTS UNDERWENT A WASHOUT PROCEDURE AS WELL; THE INFECTION WAS CURED IN 1 PATIENT. BOTH PATIENTS WITH MENINGITIS RECEIVED INTRAVENOUS AND INTRATHECAL ANTIBIOTICS, AND BOTH REQUIRED DEVICE EXPLANTATION. IN ADDITION, 25 PATIENTS (65.8%) HAD EXCESSIVE OR INCREASING WOUND ERYTHEMA. NO OBJECTIVE CRITERIA TO DOCUMENT A SUPERFICIAL INFECTION WERE PRESENT. THE WOUNDS WERE CONSIDERED SUSPICIOUS AND WERE MANAGED WITH SERIAL EXAMINATIONS AND ORAL ANTIBIOTICS. THE ERYTHEMA RESOLVED IN 24 OF THE 25 PATIENTS. IN GENERAL, OBSERVATION, WOUND CARE, AND ORAL ANTIBIOTICS ARE SUFFICIENT FOR WOUNDS THAT ARE SUSPICIOUS FOR SUPERFICIAL INFECTION. FOR DEEP-SEATED INFECTION, ANTIBIOTIC THERAPY ALONE IS GENERALLY INSUFFICIENT AND EXPLANTATION IS REQUIRED. WASHOUT PROCEDURES CAN BE CONSIDERED, BUT FAILURES ARE COMMON. REPORTED EVENT: CASE 6: A (B)(6) FEMALE PATIENT EXPERIENCED A POCKET EMPYEMA. (B)(6) AND ACINETOBACTER WERE ISOLATED FORM THE PUMP POCKET. THE PATIENT WAS TREATED WITH INTRAVENOUS VANCOMYCIN FOR 2 DAYS BUT THE PUMP WAS ULTIMATELY EXPLANTED. ORAL BACLOFEN WAS ADMINISTERED PRIOR TO EXPLANTATION AND MAINTAINED UNTIL RE-IMPLANTATION. THE PATIENT REMAINED INFECTION-FREE IN THE 12 MONTHS FOLLOWING THE DISCONTINUATION OF ANTIBIOTICS. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16176 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Required Intervention CATHETER MODEL: UNK SERIAL/LOT#: UNK