MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Human-Device Interface Problem (2949)
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Patient Problems
Pain (1994); Electric Shock (2554)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 978b128, lot#: va2e9sx, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 08-feb-2023, udi#: (b)(4).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.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 patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient reports getting painful zapping in the back and leg when the stimulator is turned on.They have tried the stimulator on different programs and at normal and low amplitudes.It was mentioned that patient had difficult lead implant.Patient has not been seen just yet, but was advised to turn stimulator off.
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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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Event Description
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Additional information was received from a manufacturer representative (rep).The rep reported that the lead implant was difficult because the implanting physician made multiple attempts to access the s3 foramen to obtain s3 motor responses.Initially the patient turned stimulation amplitude down with no improvement in painful zapping.When the patient called the rep, they were advised to turn the device off for a few days and if the zapping settled, then try all the programs which the patient had done at the time of the report.Rep noted that they would sent pertinent updates as they became available.
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Search Alerts/Recalls
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