BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3470876 · Received November 15, 2013

    Report

    Report Number
    3007566237-2013-03712
    Event Type
    Injury
    Date Received
    November 15, 2013
    Date of Event
    July 24, 2013
    Report Date
    November 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT # UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID NEU_ UNKNOWN_PUMP, SERIAL # UNKNOWN, PRODUCT TYPE PUMP. (B)(4). THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE LITERATURE.

    Description of Event or Problem · 1

    BETHOUX, F., BOULIS, N., MCCLELLAND S,<(>,<)> 3RD, WILLIS, M. A., HUSSAIN, M., MACHADO, A., MYCHKOVSKY, L., STOUGH, D., SUTLIFF, M., PIORO, E. P. USE OF INTRATHECAL BACLOFEN FOR TREATMENT OF SEVERE SPASTICITY IN SELECTED PATIENTS WITH MOTOR NEURON DISEASE. NEURORE HABILITATION AND NEURAL REPAIR. 2013;27(9):828-833. DOI: 10.1177/1545968313496325. SUMMARY: THE OBJECTIVE WAS TO ASSESS THE SAFETY AND EFFICACY OF INTRATHECAL BACLOFEN (ITB) THERAPY FOR SEVERE SPASTICITY IN PATIENTS WITH UPPER¿ MOTOR NEURON PREDOMINANT MOTOR NEURON DISEASE (U-MND). A TOTAL OF 44 PATIENTS WITH U-MND WERE REFERRED FOR DISCUSSION OF ITB THERAPY. BASELINE AND OUTCOMES DATA WERE EXTRACTED ON 35 PATIENTS FROM A CLINICAL SPASTICITY REGISTRY AT A TERTIARY REFERRAL CENTER. PATIENTS CHOOSING TO INITIATE ITB (N = 20) WERE COMPARED WITH THOSE CHOOSING CONSERVATIVE THERAPY (N = 15). AT BASELINE, LOWER AVERAGE PAIN SCORE IN THE NON-ITB GROUP WAS THE ONLY SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS. A SIGNIFICANT REDUCTION IN PAIN SCORES, MODIFIED ASHWORTH SCALE (MAS), SPASM FREQUENCY SCALE, AND REQUIREMENT FOR ORAL SPASTICITY MEDICATIONS WAS OBSERVED WITHIN THE ITB GROUP AT EARLY AND LATE FOLLOW-UP. WITHIN THE NON-ITB GROUP, THERE WAS A SIGNIFICANT INCREASE IN MAS SCORES BETWEEN BASELINE AND LATE FOLLOW-UP. A STATISTICALLY SIGNIFICANT DIFFERENCE FAVORING THE ITB GROUP WAS OBSERVED FOR CHANGE IN MAS SCORE (P <(><<)> .0001), NUMERICAL RATING SCALE PAIN SCORE (P = .04), DOSE OF ORAL BACLOFEN (P = .002) AND TIZANIDINE (P = .003), AND NUMBER OF ORAL MEDICATIONS FOR SPASTICITY (P =.002). THERE WAS NO DIFFERENCE BETWEEN THE 2 GROUPS IN THE PROGRESSION OF HIP FLEXOR WEAKNESS OR IN THE PROPORTION OF PATIENTS WHO BECAME NONAMBULATORY. OUR FINDINGS SUGGEST THAT ITB CAN EFFECTIVELY REDUCE SPASTICITY AND RELATED SYMPTOMS WITHOUT COMPROMISING FUNCTION IN SELECTED PATIENTS WITH U-MND. REPORTED EVENTS: ONE PATIENT DEVELOPED A CATHETER MALFUNCTION BUT RECOVERED WITHOUT SEQUELAE AFTER SURGICAL REVISION. NO OTHER COMPLICATIONS REQUIRING SURGERY WERE NOTED. EIGHT (8) PATIENTS IN THE ITB (INTRATHECAL BACLOFEN) GROUP CHANGED FROM AMBULATORY TO NON-AMBULATORY STATUS. IN THE DISCUSSION PART OF THIS LITERATURE ARTICLE THE AUTHOR INDICATED THAT "ALL THE PATIENTS WHO APPEARED TO LOSE AMBULATION DURING THE FOLLOW-UP PERIOD REQUIRED MORE THAN 30 SECONDS TO WALK 25 FEET AT BASELINE. THIS SUGGESTS THAT THESE PATIENTS RELIED MORE ON THEIR SPASTICITY TO WALK. IT IS DIFFICULT TO DETERMINE IF THE LOSS OF AMBULATION OCCURRED EARLIER IN THESE PATIENTS BECAUSE OF ITB THERAPY OR IF IT WOULD HAVE OCCURRED ANYWAY AS A RESULT OF DISEASE PROGRESSION. THE SUBSTANTIAL DECLINE IN AMBULATORY STATUS IN THE NON-ITB GROUP SEEMS TO SUPPORT THE LATTER." ¿SEE ATTACHED LITERATURE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592436 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S