BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP

    MDR report key: 3342198 · Received September 11, 2013

    Report

    Report Number
    3007566237-2013-02963
    Event Type
    Death
    Date Received
    September 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    August 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATE OF DEATH AND EVENT DATES WERE NOT KNOWN. THIS DATE IS BASED ON THE DATE OF PUBLICATION (MONTH AND DAY UNKNOWN). IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    DICKEY, M. P., RICE, M., KINNETT, D. G., LAMBERT, R., DONAUER, S., GERBER, M. A., STAAT, M. A. INFECTIOUS COMPLICATIONS OF INTRATHECAL BACLOFEN PUMP DEVICES IN A PEDIATRIC POPULATION. THE PEDIATRIC INFECTIOUS DISEASE JOURNAL. 2013;32(7):715-722. DOI: 10.1097/INF.0 B013E318287F02A. SUMMARY: INTRATHECAL BACLOFEN (ITB) IS AN EFFECTIVE THERAPY FOR SPASTICITY AND DYSTONIA IN PEDIATRIC POPULATIONS; HOWEVER, THERE ARE ASSOCIATED INFECTIOUS COMPLICATIONS. PATIENTS WHO HAD AN INITIAL ITB DEVICE IMPLANTED AT OUR CENTER WERE FOLLOWED TO DETERMINE THE PROPORTION OF PATIENTS WITH INFECTIOUS AND NON-INFECTIOUS COMPLICATIONS, IDENTIFY RISK FACTORS FOR INFECTION AND DESCRIBE THE CLINICAL PRESENTATIONS, TREATMENT AND OUTCOMES OF INFECTIOUS COMPLICATIONS. OVER THE 15 YEAR STUDY PERIOD, 139 PATIENTS HAD AN INITIAL ITB DEVICE PLACED. THE MEAN AGE AT PLACEMENT WAS 13.6 YEARS (RANGE- 6 MONTHS TO 41 YEARS). IN THE FIRST YEAR OF FOLLOW-UP, 83% HAD NO COMPLICATIONS OR SECONDARY PROCEDURES, 17% HAD AT LEAST ONE SECONDARY PROCEDURE AND 5% HAD AN INFECTIOUS COMPLICATION. THE MEDIAN TIME UNTIL INFECTION WAS 14 DAYS (MEAN 33 + 42 DAYS). PATIENTS WITH SECONDARY SPASTICITY OR DYSTONIA WERE MORE LIKELY TO HAVE INFECTIONS THAN PATIENTS WITH CEREBRAL PALSY (86% VS.14%; P<(><<)>0.0001). IN THE 94 PATIENTS WITH A FIRST SECONDARY PROCEDURE, 29% HAD AT LEAST ONE OTHER PROCEDURE AND 8% HAD AN INFECTION IN THE ONE YEAR FOLLOW-UP. OVERALL, 24 PATIENTS HAD 27 INFECTIONS; 22% SUPERFICIAL, 33% DEEP AND 45% ORGAN SPACE. STAPHYLOCOCCUS AUREUS WAS ISOLATED IN 50% OF THOSE WITH CULTURES OBTAINED. EXPLANTATION WAS REQUIRED IN 59% OF PATIENTS WITH AN INFECTION AND DIFFERED BY INFECTION TYPE: SUPERFICIAL (17%), DEEP (44%) AND ORGAN SPACE (92%) (P=0.004). REPORTED EVENTS: 1 PATIENT WITH AN ORGAN SPACE INFECTION DEVELOPED A VOLVULUS AND GANGRENOUS BOWEL WITHIN ONE WEEK OF AN ITB PUMP REVISION PROCEDURE AND SUBSEQUENTLY DIED. THE DEATH WAS NOT ATTRIBUTED TO THE ITB PROCEDURE OR INFECTION BY THE AUTHORS. 6 PATIENTS (139*.04) EXPERIENCED BACLOFEN OVERDOSE FOLLOWING INITIAL IMPLANT WITH ONE PATIENT HAVING A SECOND EPISODE OF OVERDOSE. THE SYMPTOMS RESOLVED WITHOUT ANY SURGICAL INTERVENTION (PAGE 9). 1 PATIENT (139*.01) EXPERIENCED BACLOFEN WITHDRAWAL FOLLOWING INITIAL PUMP IMPLANT. THE SYMPTOMS RESOLVED WITHOUT ANY SURGICAL INTERVENTION (PAGE 9). OF THE 94 PATIENTS WITH A SECONDARY ITB PROCEDURE, 16 EXPERIENCED BACLOFEN WITHDRAWAL (17%) WHICH RESOLVED WITHOUT SURGICAL INTERVENTION; 3 OF THE 16 EXPERIENCED MORE THAN ONE EPISODE OF WITHDRAWAL FOLLOWING THEIR SECONDARY PROCEDURE. PAGE 10. OF THE 94 PATIENTS WITH A SECONDARY ITB PROCEDURE, 4 EXPERIENCED BACLOFEN OVERDOSE (4%) WHICH RESOLVED WITHOUT SURGICAL INTERVENTION. THERE WERE 86 ADDITIONAL SECONDARY PROCEDURES RELATED TO SYSTEM REVISION FOR CATHETER MALFUNCTION (0.42*207). PAGE 12. THERE WAS ONE ADDITIONAL REVISION/REPLACEMENT DUE TO EROSION (OTHER THAN PATIENT #18). PAGE 12. PATIENT #1 HAD A SUBFASCIAL PUMP IMPLANT. THE PATIENT DEVELOPED A SUPERFICIAL INFECTION 180 DAYS FOLLOWING A SECONDARY REVISION/REPLACEMENT PROCEDURE WITH SYMPTOMS OF LOCAL ERYTHEMA, LOCAL EDEMA, LOCAL DISCHARGE OR ABSCESS, AND LOCAL PAIN. ORAL ANTIBIOTICS WERE ADMINISTERED FOR 7 DAYS; THE PUMP DID NOT NEED TO BE EXPLANTED. NO CULTURE WAS OBTAINED. PATIENT #5 HAD A SUBCUTANEOUS PUMP IMPLANT. THE PATIENT DEVELOPED A SUPERFICIAL INFECTION 2 DAYS FOLLOWING A SECONDARY REVISION/REPLACEMENT PROCEDURE WITH SYMPTOMS OF LOCAL ERYTHEMA, LOCAL EDEMA, AND LOCAL DISCHARGE OR ABSCESS. ORAL ANTIBIOTICS WERE ADMINISTERED FOR 7 DAYS; THE PUMP DID NOT NEED TO BE EXPLANTED. NO CULTURE WAS OBTAINED. PATIENT #8 HAD A SUBCUTANEOUS PUMP IMPLANT. THE PATIENT DEVELOPED A SUPERFICIAL INFECTION 25 DAYS FOLLOWING A SECONDARY REVISION/REPLACEMENT PROCEDURE WITH SYMPTOMS OF LOCAL ERYTHEMA, LOCAL EDEMA, AND LOCAL DISCHARGE OR ABSCESS. TOPICAL ANTIBIOTICS WERE ADMINISTERED FOR 7 DAYS; THE PUMP DID NOT NEED TO BE EXPLANTED. NO CULTURE WAS OBTAINED. PATIENT #12 HAD A SUBCUTANEOUS PUMP IMPLANT. THE PATIENT DEVELOPED A SUPERFICIAL INFECTION 6 DAYS FOLLOWING A SECONDARY REVISION/REPLACEMENT PROCEDURE WITH SYMPTOMS OF LOCAL EDEMA AND LOCAL PAIN. ORAL ANTIBIOTICS WERE ADMINISTERED FOR 7 DAYS; THE PUMP DID NOT NEED TO BE EXPLANTED. A CULTURE WAS OBTAINED FROM THE PUMP SITE AND NO ORGANISM WAS IDENTIFIED. PATIENT #7 HAD A SUBFASCIAL PUMP IMPLANT. THE PATIENT DEVELOPED A DEEP INFECTION 17 DAYS FOLLOWING A SECONDARY REVISION/REPLACEMENT PROCEDURE WITH SYMPTOMS OF LOCAL ERYTHEMA, LOCAL EDEMA, AND LOCAL PAIN. ORAL AND IV ANTIBIOTICS WERE ADMINISTERED FOR 14 DAYS. A PUMP SALVAGE PROCEDURE WAS ATTEMPTED BUT IT WAS NECESSARY TO EXPLANT THE PUMP. A CULTURE OBTAINED FROM THE PUMP SITE YIELDED METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). PATIENT #18 HAD A SUBFASCIAL IMPLANT. THE PATIENT DEVELOPED A DEEP INFECTION 465 DAYS FOLLOWING A SECONDARY REVISION/REPLACEMENT PROCEDURE WITH SYMPTOMS OF EROSION AT THE PUMP SITE, LOCAL ERYTHEMA, LOCAL EDEMA, LOCAL DISCHARGE OR ABSCESS, AND LOCAL PAIN. ORAL AND IV ANTIBIOTICS WERE ADMINISTERED FOR 10 DAYS BUT IT WAS NECESSARY TO EXPLANT THE PUMP. A CULTURE WAS NOT OBTAINED. PATIENT #19 HAD A SUBFASCIAL IMPLANT. THE PATIENT DEVELOPED A DEEP INFECTION 1 DAY FOLLOWING A SECONDARY REVISION/REPLACEMENT PROCEDURE WITH SYMPTOMS OF FEVER, LOCAL ERYTHEMA, AND LOCAL EDEMA. ORAL AND IV ANTIBIOTICS WERE ADMINISTERED FOR 15 DAYS. A PUMP SALVAGE PROCEDURE WAS PERFORMED AND THE PUMP REMAINED IMPLANTED. A CULTURE OF THE PUMP SITE WAS NOT OBTAINED. A CULTURE OF THE CEREBROSPINAL FLUID (CSF) IDENTIFIED NO ORGANISM. PATIENT #24 HAD A SUBFASCIAL IMPLANT. THE PATIENT DEVELOPED A DEEP INFECTION 45 DAYS FOLLOWING A SECONDARY REVISION/REPLACEMENT PROCEDURE WITH SYMPTOMS OF LOCAL ERYTHEMA, LOCAL EDEMA, LOCAL DISCHARGE OR ABSCESS, AND LOCAL PAIN. ORAL AND IV ANTIBIOTICS WERE ADMINISTERED FOR 28 DAYS AND THE PUMP REMAINED IMPLANTED. CULTURES WERE OBTAINED FROM THE PUMP SITE, THE CEREBROSPINAL FLUID (CSF), AND THE BLOOD AND NO ORGANISM WAS IDENTIFIED. PATIENT #9 HAD A SUBFASCIAL PUMP IMPLANT. THE PATIENT DEVELOPED AN ORGAN SPACE INFECTION 27 DAYS FOLLOWING A SECONDARY REVISION/REPLACEMENT PROCEDURE WITH SYMPTOMS OF FEVER, LOCAL ERYTHEMA, AND LOCAL PAIN. ORAL AND IV ANTIBIOTICS WERE ADMINISTERED FOR 14 DAYS BUT IT WAS NECESSARY TO EXPLANT THE PUMP. A CULTURE OBTAINED FROM THE BLOOD YIELDED METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). PATIENT #21 HAD A SUBCUTANEOUS PUMP IMPLANT. THE PATIENT DEVELOPED A SUPERFICIAL INFECTION 23 DAYS FOLLOWING INITIAL PUMP IMPLANT WITH SYMPTOMS OF LOCAL ERYTHEMA, LOCAL EDEMA, AND LOCAL DISCHARGE OR ABSCESS. ORAL ANTIBIOTICS WERE ADMINISTERED FOR 14 DAYS BUT IT WAS NECESSARY TO EXPLANT THE PUMP. A CULTURE OBTAINED FROM THE PUMP SITE YIELDED MORE THAN 3 DIFFERENT TYPES OF AEROBES. PATIENT #10 HAD A SUBCUTANEOUS PUMP IMPLANT. THE PATIENT DEVELOPED A DEEP INFECTION 31 DAYS FOLLOWING INITIAL PUMP IMPLANT WITH THE SYMPTOM OF LOCAL DISCHARGE OR ABSCESS. IV ANTIBIOTICS WERE ADMINISTERED FOR 28 DAYS BUT IT WAS NECESSARY TO EXPLANT THE PUMP. A CULTURE OBTAINED FROM THE PUMP SITE YIELDED E. FAECALIS. PATIENT #16 HAD A SUBFASCIAL PUMP IMPLANT. THE PATIENT DEVELOPED A DEEP INFECTION 38 DAYS FOLLOWING INITIAL PUMP IMPLANT WITH SYMPTOMS OF LOCAL ERYTHEMA, LOCAL EDEMA, AND LOCAL PAIN. ORAL AND IV ANTIBIOTICS WERE ADMINISTERED FOR 16 DAYS. A PUMP SALVAGE PROCEDURE WAS PERFORMED AND IT WAS NOT NECESSARY TO EXPLANT THE PUMP. A CULTURE OBTAINED FROM THE PUMP SITE IDENTIFIED NO ORGANISM. PATIENT #23 HAD A SUBCUTANEOUS PUMP IMPLANT. THE PATIENT DEVELOPED A DEEP INFECTION 623 DAYS AFTER INITIAL PUMP IMPLANT DUE TO A PRECEDING INFECTION IN POSTERIOR SPINAL FUSION HARDWARE. THE PATIENT EXPERIENCED EVER, LOCAL ERYTHEMA, AND LOCAL EDEMA. ORAL AND IV ANTIBIOTICS WERE ADMINISTERED FOR 28 DAYS AND IT WAS NOT NECESSARY TO EXPLANT THE PUMP. A CULTURE OF THE PUMP SITE YIELDED COAGULASE NEGATIVE STAPHYLOCOCCUS. CULTURES FROM THE CEREBROSPINAL FLUID (CSF) AND BLOOD IDENTIFIED NO ORGANISM. PATIENT #15 HAD A SUBFASCIAL PUMP IMPLANT. THE PATIENT DEVELOPED AN ORGAN SPACE INFECTION 12 DAYS AFTER INITIAL PUMP IMPLANT WITH SYMPTOMS OF FEVER AND LOCAL PAIN. IV AND ORAL ANTIBIOTICS WERE ADMINISTERED FOR 21 DAYS BUT IT WAS NECESSARY TO REMOVE THE PUMP. A CULTURE OF THE PUMP SITE YIELDED METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS AND A CULTURE OF THE BLOOD YIELDED COAGULASE NEGATIVE STAPHYLOCOCCUS. PATIENT #10 HAD A SUBCUTANEOUS PUMP IMPLANT. THE PATIENT DEVELOPED AN ORGAN SPACE INFECTION 9 DAYS AFTER INITIAL PUMP IMPLANT WITH SYMPTOMS OF FEVER, LOCAL ERYTHEMA, LOCAL DISCHARGE OR ABSCESS, AND LOCAL PAIN. ORAL AND IV ANTIBIOTICS WERE ADMINISTERED FOR 14 DAYS BUT IT WAS NECESSARY TO EXPLANT THE PUMP. A CULTURE OF THE PUMP SITE YIELDED E. FAECALIS. ONE PATIENT DEVELOPED AN INFECTION 668 DAYS AFTER INITIAL PUMP IMPLANT DUE TO A PRECEDING INFECTION OF A VENTRICULOPERITONEAL SHUNT. IT WAS NOT CLEAR IF THE PUMP WAS REVISED/REPLACED IN THIS PATIENT (PAGES 9, 12). ONE PATIENT DEVELOPED AN INFECTION 1478 DAYS AFTER INITIAL PUMP IMPLANT DUE TO A PRECEDING INFECTION OF A VENTRICULOATRIAL SHUNT. IT WAS NOT CLEAR IF THE PUMP WAS REVISED/REPLACED IN THIS PATIENT (PAGES 9, 12).

    Description of Event or Problem · 1

    ADDITIONAL EVENT NOT CAPTURED ON INITIAL MANUFACTURER REPORT: 3% OF 139 PATIENTS HAD AN INITIAL REVISION PROCEDURE DUE TO EITHER PUMP MIGRATION OR EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456149 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R