BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3873171 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11597
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 14, 2017
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3776-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL # (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A COUPLING PROBLEM. IT WAS STATED THAT THE PATIENT HAD IT ¿ONE OTHER TIME¿ AND SHE HAD TO GET A ¿ JUMPSTART¿ BECAUSE SHE COULDN¿T GET IT TO CHARGE. IT WAS STATED THAT THIS WAS A MONTH AGO. IT WAS REPORTED THAT THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) SURGICALLY MOVED OVER TWO INCHES LAST THURSDAY. IT WAS STATED THAT THE INS WAS MOVED BECAUSE SHE WAS ¿BIG BREASTED AND SHORT ARMED¿ AND COULD NEVER DO THIS BY HERSELF, AND BEFORE SHE HAD TO HAVE SOMEONE THERE TO HELP HER RECHARGE. THE PATIENT STATED THAT SHE THOUGHT SHE WAS CURRENTLY HAVING A COUPLING PROBLEM BECAUSE THERE WERE BANDAGES AND SHE WAS SWOLLEN IN THE HIP. IT WAS STATED THAT THERE WERE BANDAGES PRESENT OVER THE POCKET SITE. IT WAS STATED THAT THE PATIENT WAS ABLE TO GET COUPLING BOXES, BUT THEN IT WOULDN¿T KEEP THE BOXES. IT WAS NOTED THAT THE PATIENT WAS GETTING HER INCISION CHECKED NEXT WEEK. THE PATIENT NOTED SHE ¿NEVER THOUGHT ABOUT THAT, BIG BUSTED, SHORT ARMED, SHORT FRAMED AND THAT WAS WHY THE DID THIS.¿ THE PATIENT NOTED THAT SHE HAD A STIMULATOR AND A PUMP BUT THAT SHE CALLED ABOUT THE STIMULATOR TODAY. IT WAS STATED THAT THE PATIENT HAS BEEN HAVING THIS ISSUE FOR ABOUT A WEEK. **INFORMATION OMITTED FROM (B)(4): LACK OF COVERAGE IN FEET** ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER HEALTHCARE PROFESSIONAL (HCP) OR MANUFACTURER¿S REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. IT WAS STATED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY HAD DIFFICULTY CHARGING AND THE INS WAS REALLY ¿TOUCHY¿ AND THE INS RECHARGER ANTENNA MUST BE PLACED JUST RIGHT TO CHARGE IT. IT WAS REPORTED THAT THIS HAS BEEN THE CASE SINCE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350639 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 00071 YR Required Intervention