MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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Patient Problems
Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554)
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Event Date 05/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 3998cws, lot# n26491, product type: lead.Other relevant device(s) are: product id: 3998cws, serial/lot #: (b)(4), ubd: 24-mar-2007, udi#: (b)(4).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 patient who was receiving unknown drug via an implantable pump for non-malignant pain.It was reported that pt asked if the leads could ever move where they would cause pinching or shocking sensation.Patient services (pss) asked if pt had been experiencing that, pt said they think they felt a little shock, but mainly pinching and hurting.Pt clarified the first week of may they were at the beach and the last night they were there they were in extreme pain (pt said they think it was because they were bending over picking up seashells).Pt then said they went home and were fine for a while,but then in the past few weeks when it would get late into the night, pt reported the middle of their back and right underneath their chest area would hurt so bad.Pt said they were afraid their leads had moved.Pss asked, pt did not experience any falls.The patient was redirected to their healthcare provider (hcp) to further address the issue.Pss reviewed role of rep and redirected to hcp to request rep meet with pt and to have hcp check on leads/symptoms.Pt said they were already going to call their hcp after calling patient services.
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Search Alerts/Recalls
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