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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637
Device Problems Occlusion Within Device (1423); Device Or Device Fragments Location Unknown (2590); Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Granuloma (1876); Nausea (1970); Pain (1994); Vomiting (2144); Chills (2191); Therapeutic Response, Decreased (2271); Discomfort (2330)
Event Date 11/01/2017
Event Type  Injury  
Manufacturer Narrative
The main component of the device system; the other relevant components include: product id: neu_unknown_cath, serial# unknown, product type: catheter.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer's representative (rep) regarding a patient who was receiving 25mg/ml morphine at 5.8mg/day via an implantable infusion pump for an unknown indication for use.It was reported that an inflammatory mass had been diagnosed.It was reported the patient started to experience vague symptoms that were intermittent.The symptoms were only in the sides and not in the lower extremities.It was reported that shingles was ruled out.The healthcare professional sent the patient to have a magnetic resonance imaging scan (mri) and it was confirmed the patient had an inflammatory mass.The rep reported they do not know the size of the inflammatory mass.No further complications were anticipated/reported.
 
Manufacturer Narrative
Concomitant medical products: product id: 8709, product type: catheter.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp).The serial number of the pump was provided and the serial number of the catheter remained unknown.The cause of the granuloma was unknown.The patient underwent a catheter revision on (b)(6) 2018.It was reported that a magnetic resonance imaging (mri) scan would determine if the granuloma was resolved.The patient's preoperative diagnosis was back and leg pain, as well as lumbar degenerative disc disease, lumbar spinal stenosis, and an intrathecal granuloma.The patient was seen for a repeat catheter revision of their intrathecal drug delivery system.To address the granuloma, the patient was brought to the operating room, and through the small incision in their thoracolumbar spine, they removed the catheter anchor and pulled the catheter down approximately 2 vertebral levels and then re-anchored the catheter and then closed up the wound.The hcp could not access any of the fluid from the catheter through the pump side port.It was assumed that this was because there was some obstruction with the catheter when using the side port.The patient reported that the night after the procedure they had a very terrible time because of nausea, vomiting, chills, aches, and other signs of opiate withdrawal.It would seem that there indeed must be some obstruction with the catheter as the patient was not able to obtain any of her intrathecal morphine and even supple mental morphine tablets could not mitigate their severe withdrawal.Due to this the patient was there for another catheter revision.The patient was brought back to the operating room and placed in a left lateral decubitus position over a sand bag positioning device which allowed us to cradle the patient in the lateral position.A mayo stand with a pillow was used to support their right arm.Fluoroscopy was then used again to visualize the thoracolumbar catheter/anchor and, again, there did not seem to be any sharp kinks to the catheter (as was the case at the first surgery).After administration of 1 g of iv keflex, and sterile aseptic prep drape and administration of monitored anesthesia the hcp infiltrated the thoracolumbar incision with a 1-1 mixture of 0.5 percent marcaine with epinephrine, preservative-free +2 percent lidocaine, preservative-free.The hcp used a combination of sharp dissection to get down to the existing catheter and anchor.Under direct visualization there was no obvious kink or sharp bend in the catheter.The side port on the patient's pump was accessed with a 25-gauge 1.5 inch hypodermic needle and again applied negative pressure to obtain csf fluid.Again, they were unsuccessful in getting any cerebrospinal fluid (csf) return.The hcp then slowly pulled back on the intrathecal catheter with negative pressure through the side port to obtain csf and again were unsuccessful.After moving down the catheter several centimeters, the hcp went ahead and decided that they would cut the catheter to see if there was any csf flow whatsoever.There was no csf flow from the cut and of the intrathecal portion of the catheter.The hcp slowly withdrew the catheter several millimeters at a time until they had removed the entire catheter, throughout this portion of the procedure there was no csf return through the catheter.However, once a catheter was removed there was indeed a significant amount of clear csf flow through the track that was made by the existing catheter.The hcp decided to place a new catheter into this area.The hcp closed the existing catheter track with combination of electrocautery.They then used a large spinal needle and, under fluoroscopic guidance, advanced the needle until csf return was noted.Through this, the hcp then guided the new intrathecal catheter and, under lateral, live, fluoroscopic gui dance, guided the catheter tip until it was at the top of the t10 vertebrae.It should be noted that, there was excellent csf flow return from this catheter.The hcp then used the same local anesthetic and anesthetized the previous incision over the right mid quadrant and then, again, using a combination of sharp and letter cautery dissection revealed the patient's pump.The catheter port was then cleared and the pump was partially released from the anchors so that the hcp could access the catheter port and also to remove the existing, now defunct, pump catheter segment.The existing catheter was removed from the pump connection port and then old catheter was removed by gentle traction until the hcp could remove the catheter.It should be noted that a small section of the catheter seemed to be attached to the track in the right flank and it did break off.However it would estimate a severe very small section of the catheter not worthy full dissection to remove.The hcp then turned their attention back to the new intrathecal catheter and a used the manufacturer's anchor and slid it over the new catheter.Once it was in place the hcp was able to remove the intrathecal catheter guidewire and the anchor was secured in both eyelets with 2-0 ethibond suture.The hcp then anesthetized the right flank track and then used that large trocar and created a pathway between the thoracolumbar incision and the pump pocket.The free end of the new catheter was then placed through the trocar and brought out into the pump pocket.A small length of this new catheter was then clipped to remove excess length, and then the extension tubing was brought into the field and the hcp connected the intrathecal portion of the catheter to my catheter extension using the catheter connecting device and it was secured with a "click", confirming that a secure connection had been made.The catheter was then connected to the pump port and again demonstrated to have a secure connection.Then, the hcp obtained strict hemostasis into the pump pocket and vigorous irrigation of a proximally 500 ml of normal saline with antibiotic was vigorously irrigated into the pocket.There was an excess amount of catheter, which was looped behind the manufacturer's pump.The hcp then re-secured the manufacturer's pump (with the port access facing ventral) with a 2,0 ethibond suture to prevent it from "flipping." the hcp then closed the wound in layers using 2-0 vicryl suture and a 4-0 vicryl was used to close the skin and a running subcuticular stitch and the skin was then also reinforced with dermabond.This was also repeated on to the thoracolumbar incision where the hcp irrigated vigorously with a proximally 500 ml of the normal saline plus antibiotic solution and again obtained strict hemostasis and again there was a small tension relief loop of catheter in this pocket and then the pocket was closed in layers with 2-0 vicryl suture.Again, 4-0 vicryl suture was used to close the skin in a running subcuticular stitch and this was reinforced with dermabond.The patient was then awakened and transferred to the gurney and brought to the recovery room.Estimated blood loss was less than 25 ml's.It was reported the patient tolerated the procedure well.It was interesting to note that, once the procedure was done, on the back table the hcp examined the old catheter and it's noted that the ports on the distal tip of the catheter seemed to be completely obstructed.Even when connecting a tuberculin syringe with 1 ml of saline and trying to flush the catheter, they were unsuccessful.The hcp thought that perhaps, because of the intrathecal granuloma, or perhaps some other phenomenon, the catheter ports were completely obstructed and so it's not clear how the patient was getting any medication.The hcp suspected that there must be a small crack in the catheter that was either in the distal intrathecal portion or just in the epidural portion of the catheter that was delivering some medication.The hcp believed that once they pulled back on the catheter, yesterday (during the first surgery), this crack was then out of place and did not deliver any significant medication, thus causing her to go into withdrawal's.The hcp was unsure how much medicine the patient would have been receiving due to the issue.The hcp felt that the safest course of action would be to admit the patient for 23 hour observation here at (b)(6) hospital with continuous pulse oximetry.The hcp turned the pump to its lowest possible setting, that is the pump is now running in a simple continuous mode at 0.723 mg of morphine per day; this is an 85 percent decrease from the patient's previous infusion.The hcp would write orders for the patient to have intravenous morphine when necessary for severe pain and some oral analgesics as well in case of mild pain.The hcp thought this should be sufficient to prevent the patient from any further withdrawals.The hcp reported that the next day, if all goes well, and they are able to discharge the patient to home safely, they can consider changing some of their programming so that the dose rate can be up slightly and perhaps we can now activate their ptm.Then, perhaps once or twice per week over the next few weeks they could get the patient back to where the patient is very comfortable and relying on almost no oral analgesics.Also, the patient's pump was then reprogrammed several different times.First, they had to remove the pre-existing bridge bolus, then programed to clear the intra-pump saline solution and then finally to run the patient's simple continuous infusion at morphine 0.723 mg per day of the concentration morphine 15 mg per ml.In theory, the 14.5 ml estimated reserve should last 255 days.The hcp would make some adjustments over the next few days with the programming which will change the patient's low volume alarm date.No further complications were anticipated/reported.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7217278
MDR Text Key98162837
Report Number3007566237-2018-00257
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8637
Device Catalogue Number8637
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/22/2018
Initial Date FDA Received01/24/2018
Supplement Dates Manufacturer Received02/06/2018
Supplement Dates FDA Received03/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1150-2008
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
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