MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978); Insufficient Information (3190)
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Patient Problems
Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 37761, serial/lot #: (b)(4).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 who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the night prior to report, the patient's stimulation turned off and they were unable to charge the ins due to the recharger (insr) being blank.When they attempted to use the insr they received the 'charge the recharger battery' message, but the insr would not charge from the desktop charger (dtc).The dtc connector pin was broken.The patient stated they could not feel their implant stimulation in their feet, back, and legs unless the dtc was held into the insr, they confirmed they were able to feel stimulation when the dtc was plugged into the insr.
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Event Description
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Additional information was received.It was reported the problem was resolved.The stimulation turned off because the connection with the white arrow had a metal piece that bent easily affecting the effectiveness of the stimulation.The patient was sent a replacement device.
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Manufacturer Narrative
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Continuation of d10: product id 37761, serial# (b)(6), explanted: 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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Manufacturer Narrative
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H3: product id 37761, (b)(6) was returned for product analysis.Analysis found the cable had a broken connector and the cable assembly was replaced.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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