BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 7883014 · Received September 17, 2018

    Report

    Report Number
    3007566237-2018-02767
    Event Type
    Injury
    Date Received
    September 17, 2018
    Date of Event
    April 10, 2018
    Report Date
    September 17, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_PUMP, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:; PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:. CHAN DY-C, CHAN SS-K, CHAN EK-Y, ET AL. BLESSING OR BURDEN? LONG-TERM MAINTENANCE, COMPLICATIONS AND CLINICAL OUTCOME OF INTRATHECAL BACLOFEN PUMPS. SURGICAL PRACTICE. 2018;22(3):105-110. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    SUMMARY: AIM: THE INTRATHECAL BACLOFEN PUMP IS AN EFFECTIVE TREATMENT FOR SPASTICITY. HOWEVER, LONG-TERM RESULTS HAVE REPORTED PATIENTS¿ DISSATISFACTION AND PERCEPTION OF DISABILITY. POTENTIAL CAUSES INCLUDE A FREQUENT NEED FOR BACLOFEN PUMP REFILL AND RISKS OF COMPLICATIONS. THE AIM OF THE PRESENT STUDY WAS TO EVALUATE THE LONG-TERM MAINTENANCE, COMPLICATIONS AND CLINICAL OUTCOME OF INTRATHECAL BACLOFEN PUMPS. PATIENTS AND METHODS: WE CONDUCTED A 16-YEAR RETROSPECTIVE COHORT STUDY OF PATIENTS WITH SPASTICITY TREATED WITH AN INTRATHECAL BACLOFEN PUMP AT A UNIVERSITY HOSPITAL FROM 2000 TO 2016. THE PRIMARY OUTCOME WAS THE RATE OF INFECTION PER PUNCTURE FOR BACLOFEN PUMP REFILL. SECONDARY OUTCOMES INCLUDED THE INCIDENCE OF OTHER COMPLICATIONS, SUCH AS RUNNING OUT OF BACLOFEN CAUSING SYMPTOMATIC WITHDRAWAL SYMPTOMS, PUMP MECHANICAL FAILURE, PUMP BATTERY END OF LIFE AND THE NEED FOR PUMP REPLACEMENT. THE CLINICAL OUTCOME WAS ASSESSED BY THE MODIFIED ASHWORTH SCALE (MAS). RESULTS: IN TOTAL, 340 FOLLOW-UP EPISODES WITH PUMP REFILL PROCEDURES WERE RECORDED. THE AVERAGE INTERVAL BETWEEN EACH PUMP REFILL WAS 57.3 DAYS ( 15.4 DAYS). THE AVERAGE DURATION OF ADMISSION FOR EACH PUMP REFILL WAS 4 H AND 49 MIN (FROM 2 H 23 MIN TO 10 H). THERE WERE TWO EVENTS WITH ESTABLISHED INFECTION AFTER PUNCTURE FOR THE REFILL, GIVING RISE TO AN INFECTION RATE PER PUNCTURE OF 0.6 PER CENT (2/340). FOR THE LONG-TERM CLINICAL OUTCOME, AT AN AVERAGE FOLLOW-UP PERIOD OF 7.6 YEARS, THE POSTOPERATIVE MAS FOR SPASTICITY WAS 2.0 0.756, WHICH WAS SIGNIFICANTLY BETTER THAN THE PREOPERATIVE MAS AT 3.75 0.462 (P = 0.001). CONCLUSION: LONG-TERM AFTERCARE WITH BACLOFEN PUMP REFILL WAS SAFE, WITH AN INFECTION RATE OF 0.6 PER CENT PER PUNCTURE FOR EACH REFILL. LONG-TERM INTRATHECAL BACLOFEN PUMP WAS EFFECTIVE IN THE TREATMENT OF SPASTICITY WITH PERSISTENT SIGNIFICANT IMPROVEMENT IN THE SPASTICITY SCALE. REPORTED EVENTS: 1. THERE WERE TWO EVENTS WITH ESTABLISHED INFECTION AFTER PUNCTURE FOR REFILL, GIVING RISE TO AN INFECTION RATE PER PUNCTURE OF 0.6 PERCENT (2/340). 2. THERE WERE FOUR PUMPS REACHING BATTERY END-OF LIFE REQUIRING REOPERATION FOR THE IMPLANTATION OF NEW PUMP AFTER AN AVERAGE USAGE OF 8.6 YEARS (RANGE: 3¿13 YEARS). 3. THERE WAS ONE EPISODE OF SYMPTOMATIC WITHDRAWAL DUE TO THE PREMATURE CONSUMPTION OF THE PUMP BATTERY 3 YEARS AFTER IMPLANTATION OF PUMP. THE PATIENT PRESENTED WITH SPASM AND SWEATING, WHICH WERE RELIEVED BY DIAZEPAM AND BACLOFEN. OPERATION FOR CHANGE OF PUMP WITH A NEW MODEL WAS PERFORMED AFTER THE PATIENT WAS STABILIZED. INTRAOPERATIVE FINDINGS REVEALED KINKING OF THE OLD CONNECTION TUBING, WHICH CAN BE ACCOUNTABLE FOR THE EXCESSIVE BATTERY CONSUMPTION LEADING TO PREMATURE END OF LIFE OF THE PUMP. THESE WERE CORRECTED DURING THE SUBSEQUENT REOPERATION, AND THE PATIENT WAS STABLE WITH GOOD SYMPTOMATIC RELIEF 11 YEARS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723998 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R