MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97810 |
Device Problems
Intermittent Continuity (1121); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Data Problem (3196)
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Patient Problems
Pain (1994); Electric Shock (2554)
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Event Date 05/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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G2: country united kingdom medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient had issues with recharging.Manufacturer representative (rep) and healthcare professional (hcp) saw patient together in clinic.Additional information was received.The manufacturer representative (rep) reported on 2021-may-24, charging: increased stimulation on changing like a 'static' sensation when pairing.They can complete charging, but when charging, the 'frequency' goes up at the start of charging and when pr ogram change, when turning off.On (b)(6) 2021, patient reported that they were charging their ins evening and it has started clicking every 20 seconds or so, it has increased stimulation during charging and sending much pain down right leg.Device turned off as c ontinues to experience "shocks" when charging.
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Search Alerts/Recalls
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