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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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| Model Number 97714 |
| Device Problems
Migration or Expulsion of Device (1395); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508)
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| Patient Problem
Undesired Nerve Stimulation (1980)
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Event Type
malfunction
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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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He patient reported that they took a tumble down the stairs with a little assistance and the internal equipment shifted as a result.The patient noted that the fall occurred about 5-6 years prior to the report (patient was implanted on (b)(6) 2016).The patient stated that ever since their fall, when they turn on their stimulation, they feel stimulation in their right lower rib.The patient that after they fell, they went to the hospital, and were told that there was nothing wrong with them.The patient met with a manufacturer representative in (b)(6) 2021 and it was noted that they "tried to mess with it a little bit," but noted that they do not think anything is wrong with the patient's internal equipment and mentioned that "it is supposed to be the way it is." the patient met with another manufacturer representative about two weeks prior to the report for reprogramming.This manufacturer representative programmed 4 different settings to try, and the patient confirmed that their therapy is still not relieving their symptoms.The patient is now waiting on the surgeon to decide if they want to do a surgery to reposition the internal equipment.
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Event Description
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Additional information was received from the patient and it was reported that the leads in spine shifted to the right leaving the stimulator to focus mostly on right lowest rib.Manufacturing employees have been trying different programs.The issue is not resolved.
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Manufacturer Narrative
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Continuation of d10: product id(b)(6) lot# serial# (b)(6) implanted: (b)(6) 2016 explanted: product type lead 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 the patient.The patient reported that the leads had shifted to the right which now only affected the right lower rib.A manufacturer's representative (rep) set up 4 different programs to try with no effect or help.The issue wasn't resolve and there were no other actions planned.
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Manufacturer Narrative
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Continuation of d10: product id 977c165, serial# (b)(6), implanted: (b)(6) 2016, product type lead.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 the manufacturer representative (rep).Patient stated over a year ago she was involved in an abusive relationship and was pushed down a flight of stairs.There was a film indicating the paddle 565 is far right and the patient only experiences rib stimulation.Reprogramming was attempted.Patient is being seen by the hcp on may 4 at 1000 am to evaluate revising her lead.
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Manufacturer Narrative
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Continuation of d10: product id 977c165, serial# (b)(6), implanted: (b)(6) 2016, product type lead.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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