MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problem
Device Or Device Fragments Location Unknown (2590)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
Injury
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: 3889-28, lot# va0x0ra, implanted: (b)(6) 2015, 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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Information was received from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The healthcare provider (hcp) reported that the patient had the ins removed because of a possible infection in 2006, but no infection was evident.Currently the patient only has a lead left in.When advised that the manufacturer records had the patient receiving a second implant the hcp indicated that they were not aware of a second implant, but would follow-up to get accurate removal information.Patient status is unknown at the time of this report and no infection was present after explant.No device malfunctions were reported.There were no further complication reported or anticipated.
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Manufacturer Narrative
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(b)(4) should have been included in the initial report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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