BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6259766 · Received January 18, 2017

    Report

    Report Number
    3007566237-2017-00169
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    December 18, 2016
    Report Date
    January 19, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    "LAST NOC" WAS MISTAKEN TO MEAN (B)(6). IT WAS CORRECTED TO "LAST NIGHT".

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN (UNKNOWN DOSE AND CONCENTRATION) VIA AN IMPLANTABLE INFUSION PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED ON (B)(6) 2016 THAT THE HEALTHCARE PROVIDER REPORTED THAT THE PATIENT WAS HOSPITALIZED LAST "NOC" (BELIEVED TO BE NOV) DUE TO OVERDOSE OF THE BACLOFEN PUMP. IT WAS STATED THAT THE PATIENT WAS FLACCID. IT WAS STATED A MANUFACTURER'S REPRESENTATIVE INTERROGATED THE PUMP LAST "NOC" (BELIEVED TO BE NOV) AND EVERYTHING LOOKED OKAY AND THE PATIENT'S SYMPTOMS IMPROVED. IT WAS STATED THE PATIENT HAD COMPLAINED OF HEARING AN ALARM ON (B)(6) 2016 AND STATED IT SOUNDED LIKE WHEN THE OLD PUMP WOULD ALARM. IT WAS STATED THAT THE HEALTHCARE PROVIDER DID NOT HAVE A PHYSICIAN PROGRAMMER AND DID NOT FOLLOW BACLOFEN PUMP PATIENTS. IT WAS UNKNOWN IF THE PATIENTS LOGS HAD BEEN CHECKED. IT WAS STATED THE HEALTHCARE PROVIDER WOULD CONTACT THE MANUFACTURER'S REPRESENTATIVE SO THEY COULD INTERROGATE THE PUMP. THE OVERDOSE OCCURRED ON (B)(6) 2016 AND THE PUMP ALARM OCCURRED ON (B)(6) 2016. IT WAS NOTED THAT THE MANUFACTURER'S REPRESENTATIVE INTERROGATED THE PUMP ON (B)(6) 2016, BUT THE RESULTS OF THE INTERROGATION WERE UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN (UNKNOWN DOSE AND CONCENTRATION) VIA AN IMPLANTABLE INFUSION PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED ON (B)(6) 2016 THAT THE HEALTHCARE PROVIDER REPORTED THAT THE PATIENT WAS HOSPITALIZED LAST "NOC" (NIGHT, (B)(6) 2016) DUE TO OVERDOSE OF THE BACLOFEN PUMP. IT WAS STATED THAT THE PATIENT WAS FLACCID. IT WAS STATED A MANUFACTURER'S REPRESENTATIVE INTERROGATED THE PUMP LAST "NOC" (NIGHT, (B)(6) 2016) AND EVERYTHING LOOKED OKAY AND THE PATIENT'S SYMPTOMS IMPROVED. IT WAS STATED THE PATIENT HAD COMPLAINED OF HEARING AN ALARM ON (B)(6) 2016 AND STATED IT SOUNDED LIKE WHEN THE OLD PUMP WOULD ALARM. IT WAS STATED THAT THE HEALTHCARE PROVIDER DID NOT HAVE A PHYSICIAN PROGRAMMER AND DID NOT FOLLOW BACLOFEN PUMP PATIENTS. IT WAS UNKNOWN IF THE PATIENTS LOGS HAD BEEN CHECKED. IT WAS STATED THE HEALTHCARE PROVIDER WOULD CONTACT THE MANUFACTURER'S REPRESENTATIVE SO THEY COULD INTERROGATE THE PUMP. THE OVERDOSE OCCURRED ON (B)(6) 2016 AND THE PUMP ALARM OCCURRED ON (B)(6) 2016. IT WAS NOTED THAT THE MANUFACTURER'S REPRESENTATIVE INTERROGATED THE PUMP ON (B)(6) 2016, BUT THE RESULTS OF THE INTERROGATION WERE UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). THE HCP DID NOT HAVE ACCESS THE CHARTS AND WAS NOT ABLE TO RECALL ANY INFORMATION EXCEPT THAT THEY DID HAVE TO REPLACE THE PUMP. THE HCP WAS UNABLE TO PROVIDE PATIENT INFORMATION OR PHYSICIAN INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44085 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R