MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Migration or Expulsion of Device (1395); Unintended Collision (1429); Delayed Charge Time (2586); Battery Problem (2885); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was patient reported they could feel their implanted neurostimulator moved sometimes if they were sitting, laying, or standing in certain positions.Patient confirmed they had falls and that they had been falling a lot lately.Patient service specialist reviewed role of a manufacturer representative (rep) and provided them with the national answering service (nas) number.The patient was redirected to their healthcare provider to further address the issue.Caller also said patient mentioned something about implant not holding a charge.Caller said details were vague as she didn't know if it was the neurostimulator or external equipment.
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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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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received from the patient.They reported that patient was in pain due to what felt like shifting of ins and slower charging than normal.Pt wanted to meet with a manufacturer representative(rep) and said they had their hcp use the national answering service (nas) number, but they never got through to anyone after being on hold for a long time.Agent reviewed intended use of nas number and offered to send email to reps in the area, but did not guarantee a timeframe for response.
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Search Alerts/Recalls
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