MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Unstable (1667); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/22/2022 |
Event Type
Injury
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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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Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).It was reported that at the patients post operative, and during recharge teaching, the manufacturer representative (rep) noted significant difficulty getting the communicator to maintain a connection with the battery.Upon examination, the rep noticed the patient had two significant pockets of adipose tissue on his back, and the battery seemed to be trapped in a crease between them.This caused the battery to become canted when the patient was standing up, or sitting.When the patient was prone, this demarcation was not noticeable.A pocket revision is planned to slightly relocate the pocket so that it remains flat when the patient is vertical.Otherwise, the patient reported excellent pain relief and coverage.
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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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The healthcare professional reported via the manufacturer representative that the battery was too deep.This was causing issues for the patient when trying to charge.There were no known external factors that may have contributed to the issue.A pocket revision was done by moving the battery to the lower right buttocks.
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