MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Battery Problem (2885); Communication or Transmission Problem (2896)
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Patient Problems
Muscular Rigidity (1968); Pocket Erosion (2013); Seroma (2069); Ambulation Difficulties (2544); Swelling/ Edema (4577)
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Event Date 11/25/2023 |
Event Type
Injury
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Manufacturer Narrative
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Section d information references the main component of the system.Other relevant device(s) are: product id: 37651, serial# (b)(6), product type: recharger.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 patient (pt) care facility reached out to notify patient had return of parkinson¿s symptoms- rigidity, slowness.Walked through checking device.Battery depleted.Discussed recharging protocol and walked through charging.The care provider was going to help the pt charge.The pt was then able to turn device back on.The patient has a legacy recharger and was experiencing intermittent charging for several weeks, so they were going to transition to a wireless "recharger".The issue was resolved.Additional information received from the manufacturer¿s representative (rep) reported the recharging issue resolved with replacement of the recharger as the legacy recharger had a broken wire.In addition, the rep mentioned the patient had a seroma over the battery along with some thinning of the skin at the incision site and thus the battery could partially be visualized.The patient was referred to a neurosurgeon for evaluation.Additional information received from the manufacturer¿s representative (rep) reported the surgeon was unable to aspirate the swelling in the office so they were planning to take the patient into surgery to clean it out and do a scar revision.
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Event Description
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Per surgeon, no surgery date set yet.
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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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