BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3770202 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08054
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE STIM IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4) FOUND IT WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. PRODUCT ANALYSIS SUMMARY: THE INS PASSED THE FUNCTIONAL TESTING. A RECHARGE INTERVAL TEST WAS PERFORMED, THE INS BATTERY WAS DISCHARGED AT A SPECIFIC RATE FROM FULL TO LOCK MODE. THE INS BATTERY HAD SLIGHTLY REDUCED CAPACITY (9.2 DAYS VS. 10 DAYS) BUT IT WAS STILL WITHIN THE EXPECTED LIMITS FOR A BATTERY THAT IS (B)(6). (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 3 7742, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT ALL THE IMPEDANCES LOOKED GOOD AND THERE WERE NO INTRA-OPERATIVE MALFUNCTION NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) KEPT LOSING CHARGE. IT WAS NOTED THAT THE DEVICE WAS 8 YEARS OLD. IT WAS NOTED THAT A QUESTION MARK WAS PLACED NEXT TO THE QUESTION ASKING IF THE BATTERY DEPLETION AS NORMAL. IT WAS NOTED THAT THE DEVICE WAS REPLACED AND WOULD BE RETURNED. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249203 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention