BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3253213 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12463
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 2, 2013
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALIES. THERE WERE MULTIPLE MOTOR STALLS AND RECOVERIES SEEN IN THE LOGS; HOWEVER, AFTER DOING DESTRUCTIVE ANALYSIS, THE TECHNICIAN FOUND NOTHING SIGNIFICANT THAT MIGHT CAUSE A MOTOR STALL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN WANTED TO EXPLANT THE PUMP AND PUT A NEW ONE IN, BUT THE PATIENT WAS OLDER AND DID NOT WANT TO HAVE SURGERY. THEREFORE, NO SURGERY WAS SCHEDULED FOR THE PUMP AS THE PATIENT HAD NOT DECIDED WHAT HE WANTED TO DO.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PUMP HAD CONTINUED TO STALL. THE STALLS HAD BEEN SHORT, BUT SPORADIC AND HAD OCCURRED ON (B)(6), (B)(6), (B)(6), (B)(6), AND (B)(6). THE REPORTER STATED THAT NO ENVIRONMENTAL CAUSE FOR THE STALLS COULD BE DETERMINED. IT WAS INDICATED THAT THE PATIENT WAS NOT EXPERIENCING UNDERDOSING, BUT HAD NOT HAD AS GOOD OF THERAPY AS THEY THOUGHT THEY SHOULD BE GETTING.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED AND WOULD BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP¿S MOTOR HAD STALLED 5 TIMES BETWEEN (B)(6), 2013. ALL OF THE STALLS RECOVERED WITHIN 2 HOURS AND THE LONGEST REMAINED STALLED FOR 45 MINUTES. IT WAS STATED THAT THERE HAD NOT BEEN ANY MRI EXPOSURE. IT WAS UNKNOWN IF ANY TROUBLESHOOTING OR DIAGNOSTIC TESTING HAD BEEN PERFORMED, BUT THE REPORTER SPECULATED THAT THE PUMP ¿COULD POSSIBLY BE ONE OF THE ONES WITH INTERNAL SHORTING ISSUES¿. AT THE TIME OF REPORT, THERE WAS NO PATIENT INJURY AND THERE HAD NOT BEEN ANY PATIENT SYMPTOMS OR COMPLICATIONS. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. THAT SAME DAY, IT WAS ALSO REPORTED THAT THE PUMP LOGS INDICATED THAT SEVERAL MOTOR STALLS AND RECOVERIES HAD OCCURRED ON THE SAME DAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NOTHING NOTED THAT WOULD HAVE TO DO WITH A MAGNETIC CHANGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE STALL WAS THAT THE PATIENT WAS SLEEPING IN A MAGNETIC BED PURCHASED A YEAR AGO. THE PATIENT WAS ABLE TO RECEIVED EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353795 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention