MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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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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Information was received from a healthcare professional (hcp) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported the patient¿s ins and lead were removed as therapy was unsatisfactory in resolving symptoms; the system was not working as expected for at least a year.The hcp noticed that upon removal, there was a white milky type substance grown around the battery.Patient services reviewed with caller that this is not caused by a leaking battery and but is biologic material that is a body response to the ins.There were no trauma/falls reported that could be related to this issue and no unrelated medical issues.The hcp checked impedances and everything was normal except contact c/0 were showing ????.No further complications were reported or are anticipated.
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Manufacturer Narrative
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The other applicable components are: product id: 3093-28, lot# v323599, implanted: (b)(6) 2009, product type: lead.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 a hcp.It was reported that the cause of the system not working was battery corrosion.
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Search Alerts/Recalls
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