MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Disconnection (1171); High impedance (1291)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 377760, lot#: v010867, implanted: (b)(6) 2006, product type: lead.Product id: 37711, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019, product type: implantable neurostimulator.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 who was implanted with an implantable neurostimulator (ins) for complex regional pain syndrome type i and spinal pain via a manufacturer¿s representative (rep).The rep reported that the patient wasn't experiencing any symptoms.The patient was getting good stimulation coverage prior to end of service (eos) of battery which occurred sometime in (b)(6) 2019.The rep reported that upon replacing the ins on (b)(6) 2019, it was noted that one of the leads wasn't in the ins, it was just sitting outside the generator in the pocket.The rep reported that when replacing to a new ins and checking impedances, the lead which was seated in the 8-15 port had impedances all greater than 40,000 ohms.The rep reported that no interventions were taken today by the hcp.The ins was replaced.The rep reported that the hcp would take the patient back to surgery to replace the lead if needed at a later time.The rep noted that since the previous ins was at eos, no previous impedances or programmed settings were available for comparison.There were no factors known that could have contributed to the issue.The rep noted that the issues were found the day of the report.No further complications were reported.
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Event Description
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Additional information received from a manufacturer representative (rep).It was reported that the hcp expected the lead to be seeded in the ins when he opened the pocket upon replacement surgery.The lead was not in the ins at all, it had come dislodged from the ins.It was unknown if it was not tightened properly before and it came out of the ins.The cause of the high impedances was not determined.No actions were taken to resolve the high impedance.The hcp put the lead into the new ins and will bring the patient back for a lead revision at a later time if needed.This lead was not being used for patient management.No further complications were reported.
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