BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2991082 · Received March 6, 2013

    Report

    Report Number
    3007566237-2013-00690
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD; PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD; PRODUCT ID: 74002, LOT#: 0206584055, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE EXTENSIONS REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALIES FOUND. THE EXTENSIONS WERE BOTH CUT THROUGH OR SEGMENTED. FINAL DEVICE ANALYSIS OF THE ADAPTOR REVEALED THE FOLLOWING: NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT'S LEADS AND ADAPTER WERE EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED WITH VALUES OF MORE THAN 20000 OHMS. THE PATIENT HAD TWO LEADS WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE INS BATTERY WAS DEPLETED NORMALLY SO IT WAS DECIDED TO REPLACE IT WITH A NEW INS. THE TWO LEADS WERE CONNECTED TO THE POCKET ADAPTOR AND THEN TO THE NEW INS. IMPEDANCES WERE TESTED AND THEY WERE > 40000 OHMS EVEN THOUGH IT WAS ATTEMPTED TO DISCONNECT, CLEAN THE CONNECTION SITE AND RECONNECT THE LEADS. IT WAS ALSO DECIDED TO REPLACE THE OLD EXTENSIONS TO SOLVE THE IMPEDANCE ISSUE. DURING THEIR EXPLANT, ONE OF THE LEADS WAS ACCIDENTALLY CUT. IMPEDANCES ON THE ONLY LEAD LEFT WERE NORMAL SO IT WAS DECIDED TO LET IT "AS IS." HOWEVER, WHEN THE PATIENT WOKE UP, SHE COULDN'T FEEL THE STIMULATION. IT WAS STATED THAT SHE WOULD BE SOON RE-OPERATED ON TO REPLACE THE LEAD, THE EXTENSION AND THE POCKET ADAPTOR. PATIENT STATUS AT THE TIME OF THIS REPORT WAS NOTED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95142 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention