BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2921058 · Received January 17, 2013

    Report

    Report Number
    3007566237-2013-00228
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    January 2, 2013
    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

    PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. PRODUCT ID 37754, SERIAL# (B)(4) PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3550-43, LOT# N319790, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CONCLUSION CODE APPLIES TO THE IMPLANTABLE NEUROSTIMULATOR (INS), AND EVALUATION CONCLUSION CODE APPLIES TO THE LEADS (S/N (B)(4)).

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, EVALUATION CONCLUSION CODE DOES NOT APPLY TO THE IMPLANTABLE NEUROSTIMULATOR (INS) [S/N (B)(4)]; EVALUATION CONCLUSION CODE APPLIES TO THE INS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS EROSION. IT WAS STATED THE POCKET "HAD BEEN COMPROMISED" AND THE LEADS WERE "PHYSICALLY STICKING OUT" IN THE BACK. IT WAS STATED THE PATIENT WOULD HAVE AN "EMERGENCY PROCEDURE" THE DAY AFTER THE DATE OF THIS REPORT. DURING THE PROCEDURE, THE PATIENT WOULD BE CHECKED FOR AN INFECTION AND THE DEVICE WOULD EITHER BE REMOVED OR TRY TO BE PRESERVED DEPENDING ON THE JUDGMENT OF THE HEALTHCARE PROVIDER. FOLLOW UP AFTER THE PROCEDURE REPORTED THE PATIENT'S WOUND WAS IRRIGATED AND CLOSED WITH A DRAIN IN PLACE. IMPEDANCES WERE CHECKED AND WERE ALL WITHIN "NORMAL LIMITS". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION. IT WAS STATED HE HAD "GREAT OUTCOMES" WITH HIS STIMULATION AND WAS "DOING GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) POCKET WAS GOING TO BE REVISED BECAUSE THE INS HAD FLIPPED SIDEWAYS. THE FLIP WAS CONFIRMED VIA FLUOROSCOPY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT'S FIRST EXPERIENCE WAS HORRIBLE AS THE PATIENT HAD AN INFECTION, AND THE COMPLETE SYSTEM HAD BEEN REMOVED IN (B)(6) 2013 DUE TO INFECTION. IT WAS NOTED THAT THE PATIENT HAD CONCERNS BECAUSE OF HIS HEIGHT (6 FT. 4 INCHES) AND BELIEVED THAT THE SELECTION OF PRODUCT OF THE PREVIOUS SYSTEM CONTRIBUTED TO THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26689 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention