MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97714 |
Device Problems
Failure to Interrogate (1332); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 37761, serial# (b)(4), product type: recharger.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 the consumer regarding the patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that ¿the box on their back was not charging¿.It stopped working, but the recharger itself was good.It was indicated that while waiting to transfer the patient to patient services, the patient hung up.Patient services did an outbound call to the patient and they reported that the connector pin was broken/bent/loose.It was reported that the patient tried to charge today ((b)(6) 2018), but was not able to connect.They stated the connector pin appeared loose.There was no out of box failure reported and no medical/therapy problem associated with the small parts components.Patient services tired to transfer the patient to repair, but the patient disconnected again.The repair team stated they would call the patient back.No further complications were reported/anticipated.
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Search Alerts/Recalls
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