BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4314039 · Received December 10, 2014

    Report

    Report Number
    3007566237-2014-03564
    Event Type
    Injury
    Date Received
    December 10, 2014
    Date of Event
    October 17, 2014
    Report Date
    November 12, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED AGE REFLECTS THE MEAN AGE OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. THE REPORTED EVENT DATE REFLECTS THE DATE THAT THE ARTICLE WAS PUBLISHED ONLINE. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    SARDA, S., BOOKLAND, M, CHU, J., SHOJA, M. M., MILLER, M. P., REISNER, S. B., YUN, P. H., CHERN, J. J. RETURN TO SYSTEM WITHIN 30 DAYS OF DISCHARGE FOLLOWING PEDIATRIC NON-SHUNT SURGERY. JOURNAL OF NEUROSURGERY: PEDIATRICS. 2014: 1-8. DOI: 10.3171/2014.8.PEDS14109. SUMMARY: HOSPITAL READMISSION AFTER DISCHARGE IS A COMMONLY USED QUALITY MEASURE. IN A PREVIOUS STUDY, THE AUTHORS HAD DOCUMENTED THE RATE OF READMISSION AND REOPERATION AFTER PEDIATRIC CSF SHUNT SURGERY. THIS STUDY DOCUMENTS THE RATE OF READMISSION AND REOPERATION AFTER PEDIATRIC NEUROSURGICAL PROCEDURES EXCLUDING THOSE RELATED TO CSF SHUNTS. BETWEEN MAY 1, 2009, AND APRIL 30, 2013, 3098 NON-SHUNT SURGERIES DURING 2924 INDEX ADMISSIONS WERE PERFORMED AT A SINGLE INSTITUTION. DEMOGRAPHIC, SOCIOECONOMIC, AND CLINICAL CHARACTERISTICS WERE PROSPECTIVELY COLLECTED IN THE ADMINISTRATIVE, BUSINESS, AND CLINICAL DATABASES. CLINICAL EVENTS WITHIN THE 30 DAYS FOLLOWING DISCHARGE WERE REVIEWED AND ANALYZED. THE FOLLOWING EVENTS OF INTEREST WERE ANALYZED FOR RISK FACTOR ASSOCIATIONS USING MULTIVARIATE LOGISTIC REGRESSION: RETURN TO THE EMERGENCY DEPARTMENT (ED), ALL-CAUSE READMISSION, READMISSION TO THE NEUROSURGICAL SERVICE, AND REOPERATION. THE NUMBER OF ALL-CAUSE READMISSIONS WITHIN 30 DAYS OF DISCHARGE WAS 304 (10.4%, 304/2924). ADMISSION SOURCES CONSISTED OF THE ED (N = 173), HOSPITAL TRANSFERS (N = 47), AND OTHERS (N = 84). ONE HUNDRED EIGHTY OF THE 304 READMISSIONS WERE ASSOCIATED WITH AN OPERATION, BUT ONLY 153 WERE PERFORMED BY THE NEUROSURGICAL SERVICE (REOPERATION RATE = 5.2%). THESE PROCEDURES INCLUDED WOUND REVISIONS (N = 30) AND FIRST-TIME SHUNT INSERTIONS (N = 35). THE REMAINING 124 READMISSIONS WERE NONSURGICAL, AND ONLY 54 WERE ADMITTED TO THE NEUROSURGICAL SERVICE FOR ISSUES RELATED TO THE INDEX NON-SHUNT SURGERY. THUS, THE RATE OF RELATED READMISSION WAS 7.1% ([153 + 54]/2924). A LONGER LENGTH OF STAY AND ADMISSION TO THE NEONATAL INTENSIVE CARE UNIT DURING THE INDEX ADMISSION WERE ASSOCIATED WITH AN INCREASED LIKELIHOOD OF RETURN TO THE ED AND READMISSION. CERTAIN PROCEDURES, SUCH AS BACLOFEN PUMP INSERTION AND INTRACRANIAL PRESSURE MONITOR PLACEMENT, WERE ALSO FOUND TO BE ASSOCIATED WITH ADVERSE CLINICAL EVENTS IN THE 30-DAY PERIOD. LASTLY, PATIENTS WERE MORE LIKELY TO A UNDERGO REOPERATION IF THE INDEX PROCEDURE HAD STARTED AFTER 3 P.M. THE ALL-CAUSE READMISSION RATE WITHIN 30 DAYS OF DISCHARGE AFTER A PEDIATRIC NEUROSURGICAL PROCEDURE WAS 10.4%, AND THE RATE OF RELATED READMISSION WAS 7.1%. WHETHER THESE READMISSIONS ARE PREVENTABLE AND TO WHAT EXTENT THEY ARE PREVENTABLE REQUIRES FURTHER STUDY. REPORTED EVENTS: -THERE WERE 22 CASES WHERE PATIENTS WERE ADMITTED FOR BACLOFEN PUMP REVISIONS. -OF 153 REOPERATIONS, THERE WERE 5 CASES WHERE A PATIENT WAS READMITTED TO REMOVE AN INTRATHECAL BACLOFEN PUMP. THESE 153 NEUROSURGICAL REOPERATIONS INCLUDED TWO GROUPS: PLANNED AND UNPLANNED OPERATIONS. -THERE WERE 6 CASES WHERE, FOLLOWING ADMISSION AND A SURGICAL PROCEDURE, A PATIENT WAS READMITTED FOR A BACLOFEN PUMP REVISION. -AFTER BACLOFEN PUMP INSERTION AND REVISION THERE WAS AN ELEVATED RISK OF RETURN TO THE EMERGENCY DEPARTMENT (ED) WITHIN THIRTY DAYS OF THE PROCEDURE. AS THESE PATIENTS DID NOT TYPICALLY WARRANT READMISSION TO THE HOSPITAL, THEIR ED COMPLAINTS WERE ASSUMED TO BE VERY SUBTLE OR TOO MILD TO RISE TO THE LEVEL OF INPATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800105 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR Hospitalization| R