MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Therapy Delivered to Incorrect Body Area (1508); Human-Device Interface Problem (2949)
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Patient Problems
Undesired Nerve Stimulation (1980); Numbness (2415)
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Event Date 04/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of concomitant medical products: product id 978b128, lot# va2hk27, implanted: (b)(6) 2021, product type: lead, ubd: 30-jun-2023, 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 implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the patient is complaining of numbness/stimulation in the left leg, same leg as the lead placement. programming was done to try to minimize this issue.It was better for a week or two, but the patient is still complaining of numbness in the leg even when the stimulation is off.The plan is to explant the left lead and try to replace the lead on the right side. there are no known environmental/external/patient factors that may have led or contributed to the issue.An x-ray was done, but lead placement appears to be normal.Programming, including customer programming was done, but ultimately did not improve the numbness. no surgery has been scheduled.
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the patient is complaining of numbness/stimulation in the left leg, same leg as the lead placement. programming was done to try to minimize this issue.It was better for a week or two, but the patient is still complaining of numbness in the leg even when the stimulation is off.The plan is to explant the left lead and try to replace the lead on the right side. there are no known environmental/external/patient factors that may have led or contributed to the issue.An x-ray was done, but lead placement appears to be normal.Programming, including customer programming was done, but ultimately did not improve the numbness. no surgery has been scheduled.(b)(6) 2022, mpxr-944499.1 (con): additional information was received from the patient.It was reported that the patient was scheduled for a revision today.The plan was to move the lead from the right side to the left side.But the hcp was not successful in placing a new lead on the left.The patient never got appropriate sensory or motor responses.Therefore, the case was aborted and all product was explanted.No further complications were reported at this time.
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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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