MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97810 |
Device Problems
Migration or Expulsion of Device (1395); Malposition of Device (2616); Charging Problem (2892)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the patient said their previous stimulator was replaced because the battery kept trying to eject out of their body, it was superficial and it was very hard to charge.
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Manufacturer Narrative
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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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Manufacturer Narrative
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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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Additional information was received/ from the patient.The patient said/ that they had an appt with their hcp/ who directed them to turn implant off and patient requested assistance.Reviewed steps and patient connected and turned therapy off.Additional information received/ indicated that the patient reported/ that the hcp advised them to change programs/ because the program that they are on, did not work.Helped the patient connect and change programs and adjust to a comfortable level.The patient noted/ that this was their third attempt at a stimulator and they had the rechargeable one first, it worked great, but was very difficult to charge and to find the right spot.
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Search Alerts/Recalls
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