BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203134 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04739
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT DIVING (AT A DEPTH OF 30 METERS). DURING A REFILL SESSION POST DIVING, THE PHYSICIAN WAS ONLY ABLE TO FILL THE PUMP WITH 28 ML OF DRUG INSTEAD OF 40 ML. AN X-RAY OF THE PUMP WAS DONE AND IT REVEALED A DAMAGE OF THE POSTERIOR SHIELD OF THE PUMP RESERVOIR. THE PUMP WAS ¿FUNCTIONING NORMALLY¿ SO IT WAS DECIDED THAT THE PUMP REMAINS IMPLANTED. THE PATIENT DID NOT HAVE ANY SYMPTOMS AND SPASTICITY WAS ¿WELL CONTROLLED.¿ THE PUMP WAS BEING USED TO DELIVER BACLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. UPON FURTHER REVIEW, IT WAS FOUND THAT THE EVENT HAD ALSO BEEN REPORTED IN MANUFACTURING REPORT #3007566237-2013-03803. THE INFORMATION REPORTED AS PART OF THAT EVENT WAS AS FOLLOWS: "DRAULANS, N., ROELS, E., KIEKENS, C., NUTTIN, B., PEERS, K. PERMANENT MECHANICAL DEFORMATION OF AN INTRATHECAL BACLOFEN PUMP SECONDARY TO SCUBA DIVING: A CASE REPORT. SPINAL CORD. 2013;51(11):868-869. DOI: 10.1038/SC.2013.43. SUMMARY: THE OBJECTIVE WAS TO DESCRIBE THE CASE OF A SPINAL CORD INJURY PATIENT THAT WENT SCUBA DIVING RESULTING IN A MECHANICAL DEFORMATION OF HIS INTRATHECAL BACLOFEN PUMP. DIVING BELOW 10 METERS OF DEPTH CAN RESULT IN IRREVERSIBLE MECHANICAL DAMAGE OF THE DRUG RESERVOIR OF AN INTRATHECAL BACLOFEN PUMP. REPORTED EVENT: A (B)(6) MALE UNDERWENT A REFILL PROCEDURE IN (B)(6) 2012 AT WHICH ONLY 27 ML COULD BE INJECTED INTO THE RESERVOIR INSTEAD OF 40.0 ML. 3 WEEKS PRIOR, THE PATIENT WENT SCUBA DIVING TO A DEPTH OF 30 METERS BELOW SEA LEVEL. THE DRUG RESERVOIR CONTAINED ABOUT 16ML OF BACLOFEN ON THE DAY THE PATIENT WENT DIVING. HE DOES NOT RECALL ANY ALTERING OF SPASTICITY DURING OR AFTER DIVING. X-RAY REVEALED A COLLAPSE OF THE BOTTOM SHIELD OF THE BACLOFEN PUMP. THIS MECHANICAL DEFORMATION WAS BELIEVED TO CAUSE IRREVERSIBLE LOSS OF DRUG RESERVOIR CAPACITY. THE PUMP RETURNS TO NORMAL FUNCTION UPON RETURNING TO LOCAL ATMOSPHERIC PRESSURE. THEREFORE THEY DECIDED NOT TO REPLACE THE BACLOFEN PUMP IN OUR SYMPTOM-FREE PATIENT. SEE MANUFACTURER REPORT #3007566237-2013-03803 FOR THE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302282 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1