BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3142870 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01836
    Event Type
    Injury
    Date Received
    June 3, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 74002, LOT# 0206584055, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: NE U_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: 7427, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 74955136, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 74955136, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THIS EVENT WAS PREVIOUSLY REPORTED IN MANUFACTURE REPORT #3007566237-2013-00690. ADDITIONAL REVIEW REVEALED THAT THE INFORMATION WOULD BE MORE ACCURATE IF SYSTEM REPORTED ON THE CURRENT DEVICE. THEREFORE, ALL FUTURE INFORMATION CONCERNING THIS EVENT WILL BE REPORTED AS PART OF THIS MANUFACTURE REPORT. THE INFORMATION FROM THE PREVIOUS MANUFACTURE REPORT HAS BEEN RE-REPORTED FOR CONVENIENCE. 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. IN ORDER TO MAKE THE EXTENSIONS COMPATIBLE WITH THE NEWLY IMPLANTED INS AN ADAPTER HAD TO BE IMPLANTED AND WAS CONNECTED TO THE EXTENSIONS IN SITU. 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. CLEANING AND RECONNECTING THE EXTENSIONS TO THE ADAPTER DID NOT SOLVE THE ISSUE. THEREFORE, IT WAS REPORTEDLY DECIDED TO EXPLANT THE EXTENSIONS AND REPLACE THEM WITH EXTENSIONS COMPATIBLE TO THE NEW INS SO THE ADAPTER WOULD NOT BE NEEDED. 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¿ AND EXTENSIONS AND LEADS WERE LEFT AS THEY WERE. 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 STATED THE PATIENT¿S EXTENSIONS AND ADAPTER WERE EXPLANTED. 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
    243390 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention