MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
|
Back to Search Results |
|
Model Number 37714 |
Device Problems
Failure to Interrogate (1332); No Device Output (1435); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
|
Patient Problems
Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Dizziness (2194); Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554)
|
Event Date 01/01/2016 |
Event Type
malfunction
|
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
|
Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported on (b)(4) 2017 that the device was not turning on.Additional information was received on (b)(4) 2017 from the consumer reporting that they were sick.Information indicated that the patient was waiting for their programmer device.Additional information was received from the consumer on (b)(6) 2017 reporting that a hospital may be needed.The patient was in a wheelchair and in a lot of pain.Additional information was received from the consumer on (b)(6) 2017 reporting that the device was not working properly before they lost the programmer.The patient felt like they may pass out.Additional information was received on (b)(6) 2017 from the consumer reporting that overstimulation and a loss of therapy.Per the manufacturer representative the patient stated their recharger was getting to hot on (b)(6) 2017.The patient stated that their left leg was amputated below the knee in (b)(6)2016.When the patient turned stimulation on in (b)(6) 2016 after the amputation, their left leg ¿flew off the bed¿ from stimulation.On the day of the call the patient switched from program a to program b.Program b felt more comfortable but they were not feeling stimulation in their right leg.The patient could not feel stimulation in their right leg with either program a or program b.The patient was feeling stimulation in their left leg but not in their right leg on (b)(6) 2017.The programmer was not connecting and therefore unable to increase stimulation during the call; however, by the end of the call this issue resolved and the patient was able to connect the patient programmer and increase stimulation.Additional information received from the consumer on (b)(6) 2017 reported that after the program change that day ((b)(6) 2017) the patient was getting shocked.This was a sudden change.During the call, the patient was helped to change back to program a at 0.7v and the patient stated that they were not feeling the shocking sensation.No further complications were reported.
|
|
Manufacturer Narrative
|
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|