MEDTRONIC NEUROMODULATION UNKNOWN LEAD; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number NEU_UNKNOWN_LEAD |
Device Problems
Unstable (1667); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/13/2014 |
Event Type
Injury
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Event Description
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It was reported the stimloc seemed to be closed properly and hold the lead, but the stimloc was actually defective and the lead pulled out.The plate that was supposed to hold the lead was defective.The patient¿s healthcare professional (hcp) noticed in a ct scan after lead implantation that the lead was too high from the target and they had to go back to the operating room to fix it.In order to make sure the lead was in the target the hcp had to use x-ray because they could not use the guide wire any more.To fixate the lead the hcp used a surgical plate because they did not want to change the existing stimloc.After the second stage, the lead seemed to be fine.There were no patient symptoms or complications associated with this event and the patient status at the time of this report was alive with no injury.
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Event Description
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Additional information received reported the guid wire was fine.The manufacturing stated that once the guide wire was removed and the lead driver taken away from the stereotactic frame, it was not safe to put the guide wire in again and there was risk of moving the lead from its target.The patient had very good therapy outcomes and they raised up from a wheelchair after a year that were they could not walk.
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Manufacturer Narrative
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Product id: 924256, lot# 082224713a, implanted: (b)(6) 2014, product type: accessory.(b)(4).
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