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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MATTRIX; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
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MEDTRONIC NEUROMODULATION MATTRIX; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 3272-25
Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Distress (2329); Complaint, Ill-Defined (2331)
Event Date 08/16/2016
Event Type  malfunction  
Manufacturer Narrative
Concomitant products: product id: 3272-25, serial# (b)(4), product type: receiver.Product id: 3440, product type: accessory.
 
Event Description
The patient reported that they attached the antenna to their programmer, adjusted their settings, they can¿t feel their stimulation.They mentioned that the programmer is beeping when making a connection, so it is working, and there is no sign that the battery is low.The patient stated that they turned up their stimulation past to where it should be, but still can¿t feel any stimulation.The patient mentioned that they have to wear compression socks that are knee or thigh high, and it is stressful putting them on because they are afraid they did something to the wires while taking them on and off.The patient was to follow-up with their manufacturing representative to check the device.On (b)(6) 2016, it was noted that the patient was unable to connect with the implantable neurostimulator (ins) using their programmer.Additional information was received from the manufacturing representative (rep).They reported that the patient can see the values on their programmer, but still cannot feel stimulation.The rep requested that a replacement antenna be sent to see if it would resolve the issue.It was noted that the patient needed more adhesive discs as well.Additional information was received from the patient indicating that the replacement antenna did not resolve the issue.The patient also mentioned that the do not have a managing physician they are currently seeing regarding the device.The patient stated that they still are not receiving stimulation, even though their programmer seems to be connecting to the device, and showing that everything is on and ¿hooked up.¿ indication for use is unknown.Additional information received (on 2016-sep-26) from the consumer reported they were working on getting an appointment with a new physician.Additional information was received from the consumer on 2016-nov-02.It was reported that her ¿device was broken,¿ it wasn¿t working for her pain and it felt awful when she took morphine.She didn¿t know if it was the internal or the external device that was broken.It was noted that the device worked for the patient for 16 years, so she had been able to taper off morphine previously.The patient had an appointment with a healthcare provider (hcp) but missed it because of transportation; the hcp also was not currently seeing patients.A list of physicians was sent to the patient.
 
Manufacturer Narrative
Correction, updated device to main component of system.
 
Event Description
Additional information was received from the consumer.It was reported that the loss of stimulation and device not working was noticed after a shower and removal of compression hose and reapplication of device it did not stimulate.The compression hose were newly prescribed.Steps taken so far include the new antenna was used and it showed the device status was on but the patient had not received stimulation.The issue had not been resolved.The patient was scheduled to see a physician after being referred to them by the implanting physician.The patient had not seen anyone for device follow up for 16 years.
 
Manufacturer Narrative
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.
 
Event Description
Additional information was received from the consumer.It was reported that the loss of stimulation and device not working was noticed after a shower and removal of compression hose and reapplication of device it did not stimulate.The compression hose were newly prescribed.Steps taken so far include the new antenna was used and it showed the device status was on but the patient had not received stimulation.The issue had not been resolved.The patient was scheduled to see a physician after being referred to them by the implanting physician.The patient had not seen anyone for device follow up for 16 years.On (b)(6) 2016 patltr2 (con): additional information was received from a patient indicating that the loss of stimulation was due to the reapplication of a recently prescribed compression hose.The device was removed for a shower, and when reapplied, no stimulation was present.A new antenna was received and the device showed stimulation was on, but stimulation was not.The loss of stimulation issue has not been resolved at the time of this report.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MATTRIX
Type of Device
STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
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
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key6116833
MDR Text Key60623410
Report Number3007566237-2016-04152
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 01/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/28/2003
Device Model Number3272-25
Device Catalogue Number3272-25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age63 YR
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