MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97810 |
Device Problems
Migration or Expulsion of Device (1395); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
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Patient Problems
Pain (1994); Burning Sensation (2146); Shaking/Tremors (2515); Insufficient Information (4580)
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Event Date 07/28/2022 |
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 patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient stated that their bladder stimulator had worked perfectly until after they got a spinal cord stimulator on june 2022 and sometime after that, they think their bladder stimulator moved or malfunctioned when they had a "full body tremor" because, a few weeks later, they noticed vaginal issues, pain, it felt like burning from the inside out and it did not help.Pt said on july 28th they told their primary doctor about the issues, and they had been telling their bladder stimulator doctor there was something wrong, they thought the two stimulators were "crossing", but the doctor said that could not happen and they tried 3 different programs but didn't help.Pt said they saw the urologist and they went to a gynecologist but they could not figure it out.Pt also said in august (2022) they went to the chiropractor who cracked their neck and if pt pushed on their low back it felt like there was a wire in their private area, which stopped happening, when they stopped pushing on it and they think the "bladder stimulator malfunctioned." pt said finally, in november, they took x-rays or ct or mri (patient was unsure stating they had 5 mris last year) and saw the ins had moved.Pt said vaginal issues went on until they turned their device off in january (2023) when they met with a manufacturer representative, who looked at it and talked about replacing the ins with a non-rechargeable, on may 17th.Pt said as soon as it was turned off their bladder pain went away.The patient was redirected to their healthcare provider to further address the issue.
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