MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
Incontinence (1928)
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Event Date 08/01/2022 |
Event Type
Injury
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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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It was reported that the patient was sent to the hospital about 3 weeks ago because their brain was not connected to body, their body was like jelly, lying in bed and could not get up, incontinence with pee and poop.The caller stated the hospital could only do so much except supportive care.The caller stated that only the patients neurologist could help but the neurologist did not have rights to that hospital.The caller stated having to get the patient to their neurologist who stated the implantable neurostimulator (ins) is charged but the ins has been turned off for about 2 weeks.The patient was sent to rehab.They think somebody may have turned off the ins by pressing a wrong button.Patient rep states yesterday seeing low battery on the programmer , even after replacing the batteries.The patient rep stated they checked the recharger and it looked like it was working, but the recharger antenna was frayed.Patient services emailed repair to replace recharger antenna.
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Search Alerts/Recalls
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