MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
|
Back to Search Results |
|
Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); Labelling, Instructions for Use or Training Problem (1318); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Unexpected Therapeutic Results (1631); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)
|
Patient Problems
Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Arthralgia (2355); Neck Pain (2433)
|
Event Date 05/23/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 03-apr-2023, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 28-mar-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a patient implanted for non-malignant pain.The patient reported that they have problems with their stimulator.Information was received from a consumer regarding the patient.It was reported that the patient has never experienced therapeutic effect since implant.The patient was implanted to address pain in the lower lumbar, right hip, and back.Her pain stems from six rear end accidents.The patient indicated that they expected their permanent implant to be as wonderful as their temporary device, so they know relief can be achieved.The patient indicated that the system has just not taken pain away like they thought it should, or like the temporary device.The therapy is not addressing her pain.The patient has not had any change from their normal routine.They have tried changing the amount of stimulation which has increased the tingling in the patient¿s legs.The patient indicated that her legs are not the problem, and that it is her back and neck.The pain is on the patient¿s back and neck.The patient is frustrated because it is not working where she needs it.It was noted that the health care provider and manufacturer representative have it turned up (increased settings) to what they say is very high, one of the highest.The patient¿s settings are high, and it is not working.The patient stated that it is not addressing pain in the lower lumbar and right inside joint.As a result of increasing the setting, the patient is now charging 2-3 times per day.When the patient wakes up, her implantable neurostimulator is depleted, and she is very upset that she is charging this often.When the device turns off, there is no notifications (beep).So when the stimulation turns off, the patient cannot tell.The patient stated that a manufacturer representative had told her that the patient¿s settings is the highest that they have ever seen.The patient has to wear the recharger when they go out which is difficult with certain clothes like dresses.Additionally, the patient noted that it was taking too long to charge the implantable neurostimulator.The patient has to sit perfectly still, or the charging is interrupted.The patient is able to get excellent and good charging quality, but when she moves, she loses connections.The patient has tried using a recharging belt.It was reviewed that 1-2 hours is a normal charge time if the implantable neurostimulator is low.Additional information was received from a manufacturer representative regarding the patient on 2019-jul-30.It was reported that reprogramming has been exhausted.Both high dose and low dose programming has been offered.The low dose settings would save the patient¿s battery life between charging; however, the patient did not prefer the low dose frequency.The patient has tried swimming (which she normally can do if she is on her back, she cannot swim on her stomach due to limited movement in her upper cervical vertebrae), but the patient noted that her device goes into hyperstimulation and that it is so bad on her leg that it makes it impossible to swim.The patient was told to turn it down, but with her closed-head injury, it is difficult to figure out the directions from the book.The patient indicated that the pain is horrible, and she greatly desires that this device works.The patient indicated that she continues to use lidoderm pain patches,is taking oxycodone more frequently, and uses pain relief rub.Additionally, the patient noted that she was afraid to try the upper/cervical one.The patient has an appointment with her health care provider on (b)(6) 2019.Additional information received from a manufacturer representative (rep).It was reported the patient had a lead revision on (b)(6) 2019.The hcp decided to implant a paddle lead due to percutaneous lead migration.No further complications were reported.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information received from a manufacturer representative (rep).It was reported the removed leads were kept by the hospital.No further complications were reported.
|
|
Search Alerts/Recalls
|
|
|