MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97810 |
Device Problems
Display or Visual Feedback Problem (1184); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
Event Type
malfunction
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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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Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim, and gastrointestinal/pelvic floor.The reason for call was caller was attempting to place ins into mri mode.Upon connecting with handset/communicator, a power on reset (por) occurred and caller was forced to exit app.Patient noted that they charged external equipment and ins last night (ins charged from around 30% to 100% in about 35 minutes).Tss had caller and patient attempt to connect to ins with recharger but it was taking a while to connect and eventually showed 1707 code.While recharger was attempting to connect, the patient and hcp discussed that patient felt something, but no further information about this.Recharger ultimately connected to ins, showed therapy was off and confirmed ins was charging with excellent connection and ins was at 90%.Had caller attempt to connect to ins again with handset/communicator but they received "low communicator" and were unable to go further.The issue was not resolved through troubleshooting.The caller was redirected to have patient continue to recharge communicator as they will need to have it charged in order to enter mri mode and/or turn therapy back on.
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Search Alerts/Recalls
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