MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97810 |
Device Problems
Overheating of Device (1437); Communication or Transmission Problem (2896)
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Patient Problems
Burning Sensation (2146); Discomfort (2330); Insufficient Information (4580)
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Event Date 09/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 information was received from a patient (pt) regarding a recharger.The patient reported seeing a recharger not found message, the recharger would connect and then it would start beeping and lose connection and the power light on recharger turned orange.The issue started saturday.The patient reported discomfort while they were recharging on the call and said it is warm by the battery a little after they started the recharging, it was noted the site was not fully healed.The following troubleshooting steps were performed; reset the recharger, located the ins by looking for incision and/or palpating the ins, repositioned the recharger, moved the charger away from the lead, recommended using recharger over a thin layer of clothing.Suggested the patient sit down instead of standing.The troubleshooting steps that were taken on the call improved the issue, they feel it a little bit with the belt and clothing.Patient got 40% battery charge, excellent connection, and my therapy on.By end of call patient had reached 50% charge of stimulator battery.
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Search Alerts/Recalls
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