BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1082993 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-04451
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 24, 2008
    Report Date
    October 24, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF BOTH THE PUMP AND CATHETER REVEALED NO ANOMALY FOUND- NORMAL DEVICE FUNCTION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP AND CATHETER WERE EXPLANTED DUE TO A PUMP POCKET INFECTION. THE PT'S DEVICE SYSTEM WAS LATER REPLACED. NO PT SYMPTOM OR OUTCOME WAS REPORTED. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEIR PUMP HAD TO BE EXPLANTED DUE TO INFECTION AT THE INCISION SITE. THE PATIENT STATED THE INFECTION DID NOT GET INTO HIS SPINE. THE PATIENT DID NOT KNOW WHAT THE TYPE OF INFECTION IT WAS. THE PATIENT STATED HE WAS PUT IN A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE FOR A COUPLE MONTHS WITH ANTIBIOTICS. THE PATIENT STATED HE HAD ONE MEDICATION EVERY 3 HOURS AND THE OTHER MEDICATION EVERY 4 HOURS. THE PATIENT STATED THE INFECTION WAS RESOLVED, AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE PATIENT STATED THE PUMP AT THE TIME CONTAINED MORPHINE, BACLOFEN, AND ANOTHER UNKNOWN MEDICATION, ALL WITH UNKNOWN CONCENTRATIONS AND DOSES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention CATHETER MODEL 8709 LOT# J11444R49| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED