MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2024 |
Event Type
Injury
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Event Description
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Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction (incontinence, urgency, and/or frequency).It was reported that the impedance was over 4000 on each electrode.We attempted to clean the lead multiple times, and the impedance continued to exceed 4000.Dr asked for a new battery, and we had impedances over 4000 with the new battery.Dr then asked for a new lead.They removed the lead that had impedance greater then 4000 and placed the new lead and connected the new lead, to the second battery, opened we ran an impedance check on this lead and battery and each electrode was within normal limits.
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Manufacturer Narrative
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Continuation of d10: product id: 978b128, lot#: va2wyvv, implanted: (b)(6) 2024, explanted: (b)(6) 2024, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(6), ubd: 03-oct-2025, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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H3: analysis of the ins (serial # (b)(6)) found that it passed all functional testing.Analysis of the lead (lot # va2wyvv) identified a break in the insulation under {x} electrode at the distal end of the lead; consistent with explant damage.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
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