MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Connection Problem (2900); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that the connector pin broke off the desktop charger (dtc) into the recharger.During the call, patient was able to remove connector pin from insr but insr port was damaged.The patient attempted to charge the ins during call, ins showed on and 25% with poor coupling, patient confirmed their issues with poor coupling/charging from recent call (see 705074749) had continued and during call the reposition antenna screen came up on recharger while patient was attempting to charge the ins.The patient had said that because their ins battery was not charged they were "having trouble getting around" during the call, ps explained that the dbs therapy was on.
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Manufacturer Narrative
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Other relevant device(s) are: product id: 37761, serial/lot #: (b)(4).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.
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Manufacturer Narrative
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H3.Analysis of the desktop charger (s/n (b)(6) found the connector pin was damaged.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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