MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Or Device Fragments Location Unknown (2590)
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Patient Problems
Complaint, Ill-Defined (2331); Electric Shock (2554)
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Event Type
malfunction
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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# v437452, implanted: (b)(6) 2010, 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 consumer regarding a patient who was implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that about 3 years ago ¿it shorted out.¿ it was clarified that ¿the wire gave them a marvelous short, and a loom in their back.¿ they would have to have an operation to take it out and replace it, but based on their age, they decided not to do it.It was noted that the battery had not depleted.No further patient complications are anticipated or expected as a result of this event.
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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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Additional information was received.It was reported that they were sitting and reading when they got the sudden sharp electric shock in their left buttocks.They ran and got their controller and shut it down.The unit is still in their buttocks.No further patient complications are anticipated or expected as a result of this event.
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Search Alerts/Recalls
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