MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97810 |
Device Problems
Failure to Deliver Energy (1211); No Device Output (1435); Battery Problem (2885); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2024 |
Event Type
malfunction
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Event Description
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Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that everything is not working, said that stimulation turned off and unable to turn it back on.Patient said that last time recharged implanted neurostimulator was last weekend before this past weekend.When patient tried to connect to implant, received por message.Reviewed meaning of por and how to turn stimulation back on manually which patient wanted to do however explained that since battery level is very low that the stimulation will not stay for very long on until neurostimulator battery is recharged.With instruction, patient attempted to start a recharge session.After repositioning patient stated received the message that is recharging implant.Patient to spend time recharging implant, ideally all the way to 100%.Patient said that physician left the practice and sees the pa.
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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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