MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37612 |
Device Problems
Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 37651, serial#: (b)(4), product type: recharger.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 by a manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient's battery was rapidly depleting between charging sessions.He would charge to nearly full and it would be empty the next day.After interrogation, it was shown that he is charging for 1 hour a day.He was getting 4 coupling bars which is why it was taking so long to charge.The rep was requesting the new recharger for the patient.No symptoms were reported.
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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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Additional information was received from a manufacturer representative (rep) reporting the recharger has not been returned and a manufacturer representative (rep) does not have the device.They believe the cause of the ins depleting quickly and coupling issue was due to user error.The patient is autistic with obsessive compulsive disorder (ocd).The coupling is difficult due to the patient not being able to stay still and recharger hard to maintain more than 6 bars.
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Search Alerts/Recalls
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