MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Malposition of Device (2616); Human-Device Interface Problem (2949)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Insufficient Information (4580)
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Event Date 04/27/2018 |
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 regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Patient said they want their device removed because it never really helped them and it is messing with their bowels.They also said the implanting healthcare provider (hcp) messed up the surgery and hit their bladder nerve.The patient thinks one of their ureters is severed.Currently, the patient has stimulation at 0.0v and their bladder is functioning normal.As a result of what was reported, an hcp listing was sent to the patient.No further patient complications have been reported as a result of this event.
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Event Description
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Additional information was received from the patient.They reported that they had their complete system removed sometime between on (b)(6) (not quite sure) in (b)(6).Event was previously reported.
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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.
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Search Alerts/Recalls
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