BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 7832973 · Received August 30, 2018

    Report

    Report Number
    3007566237-2018-02587
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    June 10, 2018
    Report Date
    August 30, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_PUMP, LOT# UNKNOWN, PRODUCT TYPE: PUMP; PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER; PRODUCT ID: NEU_UNKNOWN_PUMP, LOT# UNKNOWN, PRODUCT TYPE: PUMP. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_PUMP, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_PUMP, SERIAL/LOT #: UNKNOWN. CITATION: PITTELKOW TP, BENDEL MA, LUEDERS DR, BECK LA, PINGREE MJ, HOELZER BC. TITLE: QUANTIFYING THE CHANGE OF SPASTICITY AFTER IN TRATHECAL BACLOFEN ADMINISTRATION: A DESCRIPTIVE RETROSPECTIVE ANALYSIS. CLIN NEUROL NEUROSURG. 2018;171:163-167. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: EXPLORATORY RESEARCH QUANTIFYING THE CHANGE OF SPASTICITY AMONG PATIENTS WHO UNDERWENT BACLOFEN INTRATHECAL DRUG DELIVERY SYSTEM (IDDS) IMPLANTATION. EIGHTY EIGHT PATIENTS WITH A BACLOFEN IDDS WERE IDENTIFIED. PATIENT CHARACTERISTICS, SPASTICITY SCORES PRE/POST INTRATHECAL BACLOFEN TEST DOSE, AND IDDS PERIOPERATIVE IMPLANTATION RECORDS WERE COLLECTED. THE PRIMARY OUTCOME WAS TO QUANTIFY THE EXTENT TO WHICH THERE WAS A CHANGE IN MODIFIED ASHWORTH SCORES (MAS) PRE/POST-INTRATHECAL BACLOFEN TEST DOSE ADMINISTRATION. SECONDARY OUTCOMES INCLUDED THE PREVALENCE OF PERIOPERATIVE IDDS IMPLANTATION COMPLICATIONS. THE MEAN AGE AT IDDS IMPLANT WAS 44.2 YEARS (RANGE, 19¿71), AND 62.5% WERE MALE. 45.5% HAD SPASTICITY OF SPINAL CORD ORIGIN, 9% OF CEREBRAL ORIGIN,AND 45.5% OF OTHER UPPER MOTOR NEURON DYSFUNCTION. REDUCTION OF MAS IN THE SPINAL CORD ORIGIN GROUP WAS 2.6 (MEAN, 3.5 TO 0.9), CEREBRAL ORIGIN GROUP WAS 2.9 (MEAN, 3.3 TO 0.4), AND OTHER ORIGIN GROUP WAS 2.5 (MEAN, 3.6 TO 1.1). IN ALL PATIENTS, POST DURAL PUNCTURE HEADACHE WAS THE MOST COMMONLY REPORTED COMPLICATION AT 22.7%. THIS REPORT OFFERS NOVEL FINDINGS DOCUMENTING A QUANTIFIABLE CHANGE OF AT LEAST TWO POINTS ON THE MAS BEFORE AND AFTER INTRATHECAL BACLOFEN TEST DOSE AS STATISTICALLY SIGNIFICANT AND COULD PROVE TO BE USEFUL INFORMATION TO ENHANCE THE DECISION MAKING PROCESS TO PROCEED WITH INTRATHECAL BACLOFEN BEYOND ASSESSMENT OF FUNCTIONAL ABILITIES. REPORTED EVENTS: IN ALL PATIENTS, POST DURAL PUNCTURE HEADACHE (PDPH) WAS THE MOST COMMONLY REPORTED COMPLICATION AT 22.7% (20/88). ADDITIONAL PROCEDURAL-RELATED EVENTS REPORTED IN THE 24 MONTH FOLLOWUP INCLUDED INFECTIONS IN 3/88 (3.4%), CATHETER-RELATED DYSFUNCTION IN 16/88 (18.2%), AND PUMP-RELATED DYSFUNCTION IN 3/88 (3.4%). REGARDLESS OF THE REPORTED COMPLICATION THAT THE PATIENT EXPERIENCED, IT WAS NOT ASSOCIATED WITH THE MAGNITUDE OF THEIR CHANGE IN MAS (PDPH: P=0.527; INFECTION: P=0.888; CATHETER-RELATED DYSFUNCTION: P=0.432; PUMP RELATED DYSFUNCTION: P=0.616). HOWEVER, THE PRESENCE OF A PDPH WAS ASSOCIATED WITH DIAGNOSTIC CLASSIFICATION, AS A GREATER PROPORTION OF PATIENTS WITH THE OTHER NEUROLOGIC INJURY DIAGNOSTIC CLASSIFICATION HAD SPINAL HEADACHES THAN WOULD HAVE BEEN EXPECTED BY CHANCE (P=0.028).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672937 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other