MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 37714 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Bruise/Contusion (1754); Erythema (1840); Pain (1994); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331); Injury (2348)
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Event Date 07/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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Information was received from a manufacturing representative (rep) and a patient who was implanted with a neurostimulator for chronic low back pain and spinal pain.It was reported that there was pain, burning, redness and bruising and the implantable neurostimulator (ins) site.No environmental, external, or patient factors might have led or contributed to the issue.The patient was asked to make an appointment with her pain doctor and let the rep know when someone can also be there.Evaluation by a doctor was performed.The issue was not resolved at the time of the report.The patient was alive with injury.No surgical intervention occurred and it was unknown if any was planned.The patient later reported that they first started experiencing the issues about the middle of (b)(6) 2016.The issues ¿just started bothering me¿ and the back was getting worse.The patient thought it would go away but it didn¿t.The issues had not been completely resolved.The patient still could not sit back on it and her back was hurting more than when it was working right.She was supposed to hear back if they were going to repair it.She hoped so as she could not do what she could when it was working properly.Her back was hurting at the littlest movement.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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