BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6339994 · Received February 17, 2017

    Report

    Report Number
    3004209178-2017-04101
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    November 2, 2015
    Report Date
    July 19, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 377860, LOT# V011576, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377860, LOT#: V011576, IMPLANTED: (B)(6) 2006: EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PREVIOUS IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO BATTERY DEPLETION AND SHE NEVER HAD ANY PROBLEMS UNTIL THIS LAST REPLACEMENT ON (B)(6) 2015. ¿IT¿S BEEN AN UNENDING NIGHTMARE SINCE IT WAS REPLACED.¿ IT FELT LIKE SHE HAD BUGS CRAWLING OVER HER BODY. SHE HAD PARTIAL TORN LIGAMENT IN HER SHOULDER BLADES AND IT WAS NOT HELPING WITH THE PAIN. SHE COULD NOT SLEEP AT NIGHT BECAUSE OF THE PAIN. SHE COULD NOT TURN OFF THE STIMULATION OR ELSE THE PAIN WOULD BE EXCRUCIATING. IT WAS OCCURRING DAILY. THE PATIENT MET WITH A MANUFACTURING REPRESENTATIVE (REP) TWICE AND WAS ABLE TO DO ADJUSTMENTS AND WAS ABLE TO RELIEVE THE CRAWLING FEELING ON HER SKIN TO GO AWAY BUT THE PAIN IN HER BACK WAS STILL THERE KEEPING HER AWAKE. SHE ALSO HAD NAUSEA AND COULD NOT EAT. THE LOCATION OF THE SYMPTOMS WAS LOCATED IN THE BACK. THE CHANGE IN SYMPTOMS WAS CONSIDERED SUDDEN, SINCE THE NEW IMPLANT. SINCE THE NEW INS WAS PUT IN IT HAD NOT HELPED WITH HER PAIN. SHE HAD AN APPOINTMENT WITH THE HEALTHCARE PROVIDER (HCP) BUT COULDN¿T MAKE IT DUE TO THE PAIN SHE WAS IN. ALL SHE COULD DO WAS SIT AND LAYDOWN BECAUSE OF THE PAIN. HER HUSBAND TOLD HER SHE WAS DETERIORATING. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDES NON-MALIGNANT PAIN. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING THE PATIENT. IT WAS DETERMINED THAT A LEAD WIRE WAS BROKEN AND REPLACEMENT SURGERY RESOLVED THE PAIN ISSUES. THE LEAD WAS RETRIEVED FROM THE SPINAL COLUMN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED FROM THE PATIENT. THEY STATED THAT THE HER PRIOR INS HAD TO BE REPLACED BECAUSE THE DOCTOR TORE THE WIRE DURING THE IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122103 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention