MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Failure to Interrogate (1332); No Device Output (1435); Battery Problem (2885); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 multiple sources (friend/family member, healthcare provider) regarding a patient (pt) who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that pt's ins was turned off yesterday (b)(6) 2023 for a surgical procedure.Caller needed assistance getting the pt's handset to connect to the ins.It was reported that the caller was unable to connect to either implant.As agent started guiding caller with connection, the call dropped.Agent called call back number and reached an operator for the healthcare facility who was unable to transfer agent to caller.They called back and technical services continued troubleshooting to turn pt's stimulation back on after hysterectomy procedure yesterday.Technical services spoke with caller and also pt's mother.When trying to connect to their right ins, they were getting message that data is lost and to caller clinician, as well as device not responding message.They tried left ins and this turned on successfully without issue.Technical services reviewed in follow up call that pt would need to go back to t heir managing healthcare provider (hcp) to get their right ins reprogrammed to address error message.
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Search Alerts/Recalls
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