MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37602 |
Device Problem
Shipping Damage or Problem (1570)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2024 |
Event Type
malfunction
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Event Description
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It was reported that, during a replacement procedure, a small scratch (package torn) was found on the (non-sterile) inner box of implantable neurostimulator (ins).Since it was discovered before the package was opened, the primary surgeon decided not to use the product in question.A spare ins was used.The blue outer package was fine, but a small tear was found on the surface of the paper of the inner (non-sterile) package containing the ins.Could not verify if there was any damage to the clean package further back.A few scratches were scraped off and looked in the back, but could not confirm.Even if the sterile part of the package was intact, the decision was not to use the product in question because it would be unsanitary once the inner box was damaged.There were no problems with the blue outer box.The scratch on the surface of the inner box is larger than when it was first discovered.The reason was that the inner box was not opened, and the opening was cut a little to check for damage to the sterile package in the back.The middle box will be returned without opening it.
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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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