BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3785274 · Received May 1, 2014

    Report

    Report Number
    3004209178-2014-08397
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 9, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# V082162, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OFFICE OF THE HEALTHCARE PROFESSIONAL (HCP) WAS CONTACTED AND THEY STATED THAT THEY ONLY INFORMATION THAT THEY HAD WAS AN OPERATING REPORT. THE HCP STATED THAT THIS WOULD BE FAXED TO THE MANUFACTURER. LATER THAT SAME DAY THE FAX WAS RECEIVED. THE PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSIS WAS: CHRONIC NEUROPATHIC PAIN STATUS POST DORSAL COLUMN STIMULATOR (DCS). IT WAS NOTED THAT THE PATIENT HAD BAD COMPLEX REGIONAL PAIN SYNDROME AND HAD NOTED A DECLINE IN THE FUNCTION OF THE DCS. THE PATIENT PRESENTED (B)(6) 2008 FOR REVISION OF THE DCS. THE RISKS AND BENEFITS, LIMITATIONS AND ALTERNATIVES TO SURGICAL EXPLORATION AND REVISION OF THE DCS WERE DISCUSSED WITH THE PATIENT AND THE PATIENT WAS ANXIOUS TO PROCEED WITH THE SURGERY. IT WAS REPORTED THAT THERE WAS A SURGERY (B)(6) 2008 AND THE PROCEDURE WAS REVISION OF DCS. IT WAS NOTED THAT UPON OPENING THE SKIN IN THE LEFT DORSAL QUADRANT THE DORSAL COLUMN BATTERY WAS IDENTIFIED AND NOTED TO BE DISCONNECTED FROM THE ELECTRODES. IT WAS NOTED THAT WHEN THE BATTERY WAS REMOVED IT WAS NOTED THAT THE END PORTION OF THE DISTAL ELECTRODE "ACTUALLY REMAINED" WITHIN THE BATTERY UNIT ITSELF. THE DESCRIPTION OF THE PROCEDURE WAS AS FOLLOWS: THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE PATIENT THEN UNDERWENT SUCCESSFUL NEUTRAL GENERAL ENDOTRACHEAL ANESTHESIA IN THE SUPINE POSITION WITHOUT INCIDENT. THE LEFT LOWER QUADRANT WAS PREPPED IN THE USUAL STERILE FASHION WITH BETADINE SCRUB, STRAIGHT BETADINE SOLUTION AND THEN WAS SUBSEQUENTLY DRAPED WITH MULTILAYERED STERILE DRAPING. THE EXISTING LEFT LOWER QUADRANT SCAR WAS RE-INCISED WITH A #10 BLADE. IT WAS NOTED TO BE JUST DEEP TO THE DERMAL LAYER AND THROUGH A SMALL AMOUNT OF SUBCUTANEOUS FAT THE DCS BATTERY WAS NOTED. THE DISTAL ELECTRODE LEADS WERE FOUND TO BE COMPLETELY DISCONNECTED FROM THE BATTERY PACK ITSELF. WHEN THE POCKET WAS DISSECTED THE OLD BATTERY WAS REMOVED AND IT WAS NOTE THAT A PORTION OF THE DISTAL ELECTRODE LEADS WERE FOUND TO BE REMAINING WITHIN THE BATTERY ITSELF. THE LEADS WERE REMOVED THROUGH THIS WOUND AND THEN THE WOUND WAS COPIOUSLY IRRIGATED WITH STERILE SALINE AND BACITRACIN IRRIGATION. THE POCKET WAS THEN RE-APPROXIMATED WITH 2-0 VICRYL SUTURES AND THEN THE SUBCUTICULAR LAYER WAS RE-APPROXIMATED WITH 2-0 VICRYL SUTURES AS WELL. THE SKIN EDGES WERE THEN CLOSED WITH THREE LAYERS OF DERMABOND AND THEN A STERILE 4 X3 DRESSING AND TEGADERM WERE APPLIED. THE ENTIRE SETUP WAS THEN TAKEN DOWN AND SUBSEQUENTLY THE PATIENT WAS TRANSFERRED BACK TO THE STRETCHER. IT WAS NOTED THAT CARE WAS TAKEN TO TURN THE PATIENT PRONE ON APPROPRIATE PADDING MATERIAL. A C-ARM WAS THEN USED TO RADIOGRAPHICALLY CONFIRM THE DCS LEAD AT APPROXIMATELY THE LEVEL OF T10 AND T11. THE OPERATIVE FIELD WAS THEN PREPARED IN THE USUAL STERILE FASHION WITH BETADINE SCRUB, STRAIGHT BETADINE SOLUTION AND THEN WAS SUBSEQUENTLY DRAPED WITH MULTILAYERED STERILE DRAPING. A SKIN INCISION WAS THEN FIRST MADE AT THE SUPERIOR ASPECT OF THE OLD SCAR. THE STANDARD SUBPERIOSTEAL DISSECTION WAS THEN ACCOMPLISHED AND REVEALED NO SIGN OF THE ELECTRODE WIRES OR THE ANCHORING DEVICES. THE WOUND WAS THEN CLOSED WITH 2-0 VICRYL SUTURES IN THE FASCIA, 2-0 VICRYL SUTURES IN THE SUBCUTANEOUS PLAN AND 4-0 MONOCRYL RUNNING SUBCUTICULAR STITCH IN THE SKIN. ATTENTION WAS THEN FOCUSED ON THE INCISION ROUGHLY COMMENSURATE WITH THE T11 SPINOUS PROCESS. A STANDARD SUBPERIOSTEAL DISSECTION WAS THEN ACCOMPLISHED. UNDER LOUPE MAGNIFICATION AND HEAD LAMP ILLUMINATION, WITH RADIOGRAPH CONFIRMATION, A CONFIRMATION OF LEKSELL, FULTON AND KERRISON INSTRUMENTATION WAS UTILIZED TO FASHION A STANDARD LAMINECTOMY WITH EXPOSURE OF THE SPINAL CORD AT THE LEVEL OF T11. THE DISTAL ELECTRODE LEADS FROM THE OLD DCS WERE IMMEDIATE IDENTIFIED UPON REMOVING THE LAMINA. THE LEAD WAS THEN SUCCESSFULLY REMOVED IN ITS ENTIRETY WITHOUT INCIDENT. THE NEW DCS WAS THEN ADVANCED AND PLACED SUCCESSFULLY T10-11 LEVEL. THESE ELECTRODE LEADS WERE THEN ANCHORED DOWN TO THE REMAINING INTERSPINOUS LIGAMENT. AN INCISION WAS THEN MADE IN THE RIGHT LOWER BACK SUPERIOR TO THE ILIAC CREST. A TROCAR WAS THEN USED TO TUNNEL THE NEW ELECTRODE LEADS FROM THIS LOWER BACK INCISION TO THE DCS. THE ELECTRODES WERE THEN COVERED WITH PROTECTIVE SHEATHS AND SECURED WITH 2-0 SILK TIES. THE DISTAL LEADS WERE THEN CONNECTED TO THE BATTERY SUCCESSFULLY AND THE DCS WAS PLACED IN A SUBCUTANEOUS POCKET JUST DEEP TO THE DERMAL LAYER BELOW A SMALL AMOUNT OF SUBCUTANEOUS FAT. THE WOUNDS WERE THEN COPIOUSLY IRRIGATED WITH STERILE SALINE SOLUTION AND BACITRACIN IRRIGATION AND ATTENTION WAS TURNED TOWARDS CLOSURE. THE POCKET WAS LOOSELY APPROXIMATED USING 2-0 VICRYL SUTURES AND THEN THE SUBCUTICULAR LAYER WAS RE-APPROXIMATED WITH 2-0 VICRYL SUTURES AS WELL. A LAYER OF DERMABOND WAS THEN APPLIED TO THE SKIN EDGES. THE BACK INCISION WAS CLOSED TO 2-0 VICRYL SUTURES IN THE FASCIA, 2-0 VICRYL SUTURES IN THE SUBCUTANEOUS PLANE AND 4-0 MONOCRYL IN THE SKIN IN RUNNING SUBCUTICULAR FASHION. A LAYER OF DERMABOND WAS THEN APPLIED TO THIS WOUND AS WELL. ALL THE WOUNDS WERE COVERED WITH STERILE GAUZE DRESSINGS AND TEGADERM. THE PATIENT WAS THEN TRANSFERRED BACK TO THE STRETCHER AND EXTUBATED WITHOUT INCIDENT. THE PATIENT WAS TRANSFERRED TO THE "PACU"" IN STABLE CONDITION. IT WAS NOTED THAT THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 200 CC. URINE OUTPUT WAS NONE AND NO SPECIMENS WERE SENT TO PATHOLOGY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD PREVIOUS SURGERIES (SEVERAL IMPLANTED). IT WAS STATED THAT THE DOCTOR COULDN'T GET IT RIGHT AND THE LEAD WIRES KEPT BREAKING. THEY BROKE 3 TIMES, HE KEPT SCREWING IT UP, PUTTING IT IN THE SAME SPOT, THE POCKET WAS TOO BIG, THE BATTERY WAS FLIPPING AROUND, AND THE WIRES KEPT BREAKING. IT WAS THOUGHT IT WAS 2007 - SHE HAD SURGERY IN MARCH, AUGUST, AND AGAIN IN (B)(6). IT WAS STATED SHE WAS NOT SURE IF THE DEVICE WAS CHANGED OR NOT AND THAT THERE WAS NOTHING WRONG WITH THE EQUIPMENT, "IT WASN'T YOUR GUYS' FAULT, IT WAS THE DOCTOR KEPT PLACING IT IN THE SAME SPOT AND THINKING THERE WOULD BE A DIFFERENT OUTCOME." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261538 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention