BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2689480 · Received August 9, 2012

    Report

    Report Number
    3004209178-2012-06698
    Event Type
    Injury
    Date Received
    August 9, 2012
    Report Date
    July 12, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    PRODUCT ID: 3888-56, LOT#: V444661, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT#: V822731, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT#: V433259, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT#: V841065, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: RECHARGER PRODUCT ID: 37744 LOT#: SERIAL#: (B)(4), IMPLANTED: (B)(6) 2011,PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708240, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A 4TH RE-ORIENTATION PROCEDURE FOR HIS IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PATIENT WAS THIN AND THE INS POCKET WAS TIGHT, SO HIS INS DID NOT MOVE AROUND. IT WAS THE PATIENT'S 4TH TIME FOLLOWING A PROGRAMMING OF HIS INS THAT THE DEVICE DID NOT DISPLAY THE CORRECT POSITION. IT WAS NOTED THAT THE REPROGRAMMING WOULD ONLY LAST 1-2 WEEKS BEFORE DISPLAYING THE INCORRECT ORIENTATION. IT WAS NOTED THAT THE PATIENT HAD ONLY ONE ADAPTIVE STIMULATION (AS) GROUP PROGRAMMED AND NO OTHER NON-AS GROUP PROGRAMMED. THE MANUFACTURER REPRESENTATIVE RE-ORIENTED THE PATIENT'S INS AGAIN AND THE INS WAS RECOGNIZING THE PATIENT'S POSITION; BEFORE THE REPRESENTATIVE RE-ORIENTED THE DEVICE, THE INS WAS NOT RECOGNIZING THE PATIENT'S POSITION. THE PATIENT WAS CONSIDERING HAVING THE DEVICE EXPLANTED. IT WAS NOTED THAT THE TRANSITION TIMES IN BETWEEN POSITION CHANGES WERE SET TO DEFAULT AMOUNTS EXCEPT "UPRIGHT POSITION, LYING FRONT", WHICH WAS SET TO 20 SECONDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT 3 LEADS HAD MIGRATED TO THE IMPLANTABLE NEURO STIMULATOR (INS) POCKET, AND THE INS HAD MIGRATED OVER THE SPINE CAUSING PAIN WHEN PRESSURE WAS APPLIED. IT WAS REPORTED THE PATIENT HAD THEIR ENTIRE SYSTEM REMOVED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention