MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Pocket Stimulation (1463); Therapy Delivered to Incorrect Body Area (1508)
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Patient Problems
Muscular Rigidity (1968); Undesired Nerve Stimulation (1980); Cramp(s) /Muscle Spasm(s) (4521); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
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 patient (pt) who was implanted with an implantable neurostimulator (ins) for urge incontinence and urinary/bowel dysfunction.It was reported that since just before their follow-up appointment on dec 8th, they had been having spasms down their right thigh.Patient said they thought it was just because they had not done anything for a month or may have moved wrong, so they waited another week, and tried to walk as much as they could.It eased up so they decided to do chair yoga and some exercise and in the last couple of day, it had been tight.Pt said they called the doctor's office and the nurse told them to call [manufacturer] and turn it down.Pt requested assistance and was successful to synch with their ins and decrease stimulation down to 0.1, confirming it felt good and that it was not going down their leg.They just noticed it at the incision site.Patient services recommended pt let their doctor know.Pt said the doctor's office told them that the manufacturer representative (rep) will call them on monday (2024-jan-15).Patient services reviewed some stimulation sensation and therapy effect information.Patient services offered and sent email with quick guide and device information.Patient was redirected to their doctor.Patient will maintain stimulation level and will continue to track symptoms.
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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 healthcare professional (hcp).The hcp reported that the patient was feeling "electrical pulses running down their leg." they turned therapy 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 healthcare professional (hcp).The hcp reported that the patient, since having the device placed on (b)(6) 2023, felt like electricity was running down their leg.They get some relief while doing yoga, but then it just returns.The device was turned off.
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Search Alerts/Recalls
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