MEDTRONIC MED REL MEDTRONIC PUERTO RICO 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 Problems
No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 3093-28, lot# v741591, implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 3093-28, serial/lot #: (b)(4), ubd: (b)(6) 2015, 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 healthcare provider regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal floor.It was reported by a healthcare professional, possibly an mri tech on (b)(6) 2018 that the patient had a lead tip left at their sacrum, but the rest of the implant had been removed.Caller didn't know when it was removed and was calling because the patient needed an mri.No patient symptoms were reported.On (b)(6) 2018 the device - managing healthcare professional reported the cause of the lead tip remaining in the patient after explant was that the lead fragmented at the time of product removal.No further complications were reported or anticipated.
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Manufacturer Narrative
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The date for the first supplemental sent should have been (b)(6)2018 product id (b)(4) lot# v741591 implanted: (b)(6)2012 explanted: (b)(6)2015 product type lead.Product id: (b)(4).Serial/lot (b)(4), ubd: (b)(6)2015, (b)(4) information references the main component of the system and other applicable components are: applies to the lead.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction was made: adverse event was added: product id (b)(4) lot# (b)(4) serial# implanted: (b)(6) 2012 explanted: (b)(4) 2015 product type lead information references the main component of the system.Other relevant device(s) are: product id: (b)(4), serial/lot #: (b)(4) , ubd: (b)(4) 2015, 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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Additional information was received from the healthcare professional: the patient was not seen in their office since 2016.No further complications were reported or are anticipated.
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Manufacturer Narrative
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(b)(4).Continuation of concomitant products: product id 3093-28; lot# v741591; implanted: (b)(6) 2012; explanted: (b)(6) 2015; product type: lead.Other relevant device(s) are: product id: 3093-28, serial/lot #: (b)(4), ubd: 02-jun-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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