MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97810 |
Device Problems
Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2022 |
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 as they were unable to connect to the recharger.No cause known.They replaced the recharger.Additional information was received.The manufacturer representative (rep) reported on occasions patient needing to charge for 3 hours.Patient was seen for issues with the charging of the ins , on 10% and keeps disconnecting.New recharger issued, but continued to experience charging issues.Patient's partner has to hold and press the charger and takes up to 3 hours.
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Search Alerts/Recalls
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