MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97714 |
Device Problems
High impedance (1291); Migration or Expulsion of Device (1395); Pocket Stimulation (1463); Charging Problem (2892); Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)
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Patient Problems
Fall (1848); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
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Event Date 08/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 977a260, serial (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.Product id: 977a260, serial (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.The main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot (b)(4), ubd: 22-jun-2021, (b)(4); product id: 977a260, serial/lot (b)(4), ubd: 22-jun-2021, (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 manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the ins was moved to a different location on (b)(6) 2018 due to the patient having trouble reaching the ins to recharge.The trouble recharging began in (b)(6) 2017.The rep met with the patient on (b)(6) 2018 to program.When stimulation was turned on, the patient felt ins site pain at 0.7 v and couldn¿t tolerate further programming.The patient doesn¿t feel pain at the pocket site with the ins off.The patient complained of stimulation in the battery pocket.Impedances were as follows: 1 - 765 ohms, 2 ¿ 917, 3 ¿ 972, 4 ¿ 959, 5 ¿ 995, 6 ¿ 1034, 7 ¿ 1014, 8 ¿ 845, 9 - >10k, 10 ¿ 867, 11 - >10k, 12 ¿ 787, 13 ¿ 702, 14 - >10k, 15 - >10k ohms.The patient was programmed on electrodes 4, 5, 6, 7.Therapy was fine prior to the revision.The rep said the cause of the pocket site pain was likely due to a fluid short.It was suggested the rep wait until the patient heals and hopefully the pocket would not be as sensitive to the stimulation, but a fluid short is not likely to go away.X-rays were performed, and it was determined that the leads were pulled into the battery pocket.The battery and leads were fully explanted.It was noted the patient falls every day.The issue was reported to be resolved.No further complications were reported.
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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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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