Model Number 37612 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/01/2013 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 37601, serial#: (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.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 from a healthcare professional (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient hadnt charged his ins since 2013.It was reviewed the possibility of recovering the ins given the time its been in overdischarge.It was reviewed that patient's estimated 9 year battery life should be okay since the 9 years don¿t count the time in a overdischarged state.The hcp was debating whether to remove the ins or try to recover it.No symptoms were reported.No further complications were reported/anticipated.
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Manufacturer Narrative
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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 the consumer reporting there is no plans to charge and no plans to remove.
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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.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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Search Alerts/Recalls
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