MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number ADDR01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Dry Eye(s) (1814); Headache (1880); Hearing Impairment (1881); Blurred Vision (2137); Abdominal Cramps (2543); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/03/2023 |
Event Type
Injury
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Event Description
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It was reported that by the patient that "i had an experience that i did not know was normal to me, it was before i had my new device implanted.They put the monitor on me, and i had a shock and smoke and fire sensation and it only happened for a minute, and i could not see, hear, or talk or anything when the tech was testing the pacemaker.It was very scary.And when they pulled the machine off me i had a light headache and a light stomach ache.After i recovered a little, they put me into surgery to get my pacemaker replaced".The anesthesiologist stated the patient basically died for a minute.The patient reported a burning sensation through their eyes which was a horrible sensation.The implantable pulse generator (ipg) was explanted and replaced due to normal elective replacement indicator (eri).Following the device changeout, the patient felt their corneas were completely dry, and the eye doctor said this could potentially be related to the anesthesia.The new ipg remains in use. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Continuation of d10: 5568-53 lead, implanted on (b)(6) 2005.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.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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