MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number B35200 |
Device Problems
Break (1069); Failure to Interrogate (1332); Low impedance (2285); Communication or Transmission Problem (2896); Device Damaged by Another Device (2915)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_lead, lot#: unknown, product type: lead.Product id: neu_unknown_lead, lot#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.Product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the tablet kept crashing/saying telemetry failed and had a very difficult time reconnecting to the implantable neurostimulator (ins) wirelessly.After finally being able to check impedances it came back normal however after the surgery the impedance was rechecked one pacu and the left lead came back with abnormal short circuit impedances on some of the bipolar configurations.Unknown as to the cause of the assembly issue.Unknown as to the cause of the telemetry issues as well as the short circuit.The right lead at implantation looked to be a little crimped possibly from the lead end cap but apparently this is not the lead that had an issue.Impedances were check numerous times on the operating room and were all normal.Impedances were check numerous times and the lead extension connection was palpated while trimming impedance to see if it made anything change but it did not.The socket assembly would not move smoothly for the nexframe and felt like it was catching making it difficult to align to target.Unknown reason for this to occur.A new one was used and the issue was resolved.The error code that was seen on the tablet was (b)(4).
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Manufacturer Narrative
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D11: section d information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, lot#: va2382j.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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Additional information was received from a manufacturer representative (rep) reporting both leads were on the left hemisphere because this was a globus pallidus (gpi)/ventral intermediate nucleus (vim) combo lead placement.The socket assembly was not used, was replaced, and returned for analysis.The new socket assembly worked well and alignment was able to be achieved.It is believed that the crooked lead may have been a result of tightening the lead boot.It is unknown why the nexframe socket assembly was not moving smoothly and unknown why there were telemetry issues while trying to communicate with the ins.The next ante socket assembly was swapped out for a new one to resolve the issue.The lead impedance was checked and came back as normal after it was attached to the extension.To resolve the telemetry failure, the communicator was draped into a sterile bag, placed directly over the ins to communicate a nd to verify impedances.
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