MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)
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Patient Problems
Pain (1994); Complaint, Ill-Defined (2331); Impaired Healing (2378)
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Event Date 11/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of medical devices: product id 3889-28, lot# va1kkx6, implanted: (b)(6) 2017, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 08-sep-2021, udi#: (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 consumer regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that the patient¿s device was located on their left side but was ¿still affecting their right side;¿ they had experienced pain from their device ¿pretty much since implant.¿ it was mentioned that ¿around (b)(6) 2017,¿ they ¿had a nerve block¿ and needed to have nerve ablation done.It was noted that they did an x-ray last week and found that the lead was ¿displaced and was resulting in nerve pain when it was on.It was noted that the patient had turned their device off because of the pain, and it was going to be replaced on thursday.No further patient complications are anticipated or expected as a result of this event.
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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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Additional information reported that the device was replaced however said that the procedure was horrible, said that it took the hcp longer to place and the recovery was long.
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Search Alerts/Recalls
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