MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)
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Patient Problems
Pain (1994); Burning Sensation (2146); Electric Shock (2554)
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Event Date 01/24/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Country united kingdom.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 consumer via a manufacturer¿s representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use it was reported that patient with implantable neurostimulator (ins) who was recently implanted, reported they have been experiencing electric shock sensations when they go near certain electronic devices such as spider repeller plugs and the radio.The impedance checks were all fine, and stimulation was in a good location at a low threshold.
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Manufacturer Narrative
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Concomitant medical products: product id neu_unknown_lead lot#/serial# unknown product type lead medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received from a manufacturer representative (rep).It was reported that the patient was implanted for fecal incontinence.The rep reported that they obtained a response from the surgeon who the patient was seen by.The response was as noted "i spoke to the patient last week and saw them today to review in person.Patient has turned off the spider repeller plugs and radio and unplugged them, and is continuing to have shocks unrelated to the devices and not when they are near the devices.Patient started having the shocks after the device was implanted and before stimulation was switched on by us.Patient is being reviewed by [hcp] at the end of the month as they are also reporting significant pain and burning in the coccyx region and over the battery site." they also noted that the patient was feeling the shock-like sensation mostly at the ins but also at the lead location around the sacrum.The patient reported feeling the shock sensation every time they passed the spider repeller and radio.The devices were unplugged but patient was still continuing to experience shocking not in the vicinity of the devices throughout the day.Patient does not come into contact with or touch metal objects when feeling this shock sensation and it was noted the shocks can be felt in any position.It was also noted the shock sensation is felt when the stimulator is off.
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