MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Failure to Deliver Energy (1211); High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 3889-28, lot#: va1shp2, implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 21-jun-2022, 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 consumer via a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient experienced symptom return, and did not feel stimulation after increasing.Impedances were checked and elevated on electrodes 1, 2, and 3.Stimulation was increased to 8.0 volts, and they did not feel anything on all programs.The patient denied having fallen or any other event.A healthcare provider was spoken with regarding scheduling for a lead revision.The issue was not resolved at the time of the report, but surgical intervention was planned.
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Event Description
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Additional information was received.The patient needed an mri, the mri technician reported that the patient said they met with the rep the week prior and they told them their lead was faulty and only one of their leads were working.The mri tech had no additional information.No patient symptoms were reported.Additional information was received from the rep, they reported the cause of the high impedance was unknown, the patient denied falling or injury.It was noted they would be scheduled for lead revision.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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