|
MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
| Model Number NEU_ENS_STIMULATOR |
| Device Problems
Break (1069); High impedance (1291); Device Contamination with Chemical or Other Material (2944); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
| Patient Problems
Pulmonary Edema (2020); Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 10/19/2023 |
|
Event Type
Injury
|
|
Event Description
|
|
It was reported that during the dbs procedure, the hcp implanted a lead and connected the lead testing cable to perform connectivity test.As a protocol, the hcp rotated the lead testing cable around the lead to break the layer that may come on the contacts, then the connectivity test was made and failed.After that, the hcp drew the lead and observed an unknown stain on the electrodes, so another lead was opened and implanted, which also presented failure in connectivity test.Another lead testing cable was opened and a new measurement of connectivity test was made but also presented failure.Then the hcp drew that lead and another lead was opened and implanted, which also present failure in connectivity test.After that, the hcp drew that lead and opened a new lead (model 3389) and implanted it.A new connectivity test was made with a twist lock connector cable and it was ok.The lead remained implanted for the right side of the brain.Another hcp decided to test the three leads but they did not rotate the lead testing cable around the lead.They made a vertical movement with the lead testing cable making friction on the lead, as a result, the connectivity test was ok for the three leads.Due to that, the hcp decided to implant one of the lead on the left side of the brain.Factors that may have led or contributed to the issue was that it seemed the layer that came on the contacts was larger than usual.Troubleshooting included cleaning the lead with sterile water, lead stylet revised on position, measurement made with two external neurostimulator (ens), and measurement made with two clinician programmers.There were patient complications associated with this event.The patient remained in clinic and in intensive care unit observation because of low saturation symptom at lead location.Clinical exams will be performed for diagnosing heart attack and pulmonary thromboembolism.It was unknown if the symptom was associated due to extended time of the procedure.
|
| |
|
Manufacturer Narrative
|
|
Concomitant products information references the main component of the system.Other relevant device(s) are: product id: b3300542, serial/lot #: (b)(6), ubd: 23-dec-2024, udi#: (b)(4) ; product id: b3300542, serial/lot #: (b)(6), ubd: 23-dec-2024, udi#: 0 0763000451912 ; product id: b3300542m, serial/lot #: (b)(6) , ubd: 27-feb-2025, udi#: 00763000451936 ; product id: 3389-40, serial/lot #: (b)(6), ubd: 21-jul-2026, udi#: (b)(4).The country of event is co.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.
|
| |
|
Event Description
|
|
Additional information was received stating according to the family the cause of the low saturation was unknown.The patient left the hospital on (b)(6).The low saturation was resolved on (b)(6).This was confirmed with the physician.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Event Description
|
|
Additional information was received clarifying that the low saturation symptoms are related to pulse oximetry readings.The physician provided the following findings of the clinical evaluation: a troponin blood test was performed, and the result was normal.A chest x-ray was requested and lung congestion was found, therefore it was concluded that low saturation occurred due to fluid excess from anesthesia.It was unknown if the symptoms were associated due to the extended time of the procedure of lead location.
|
| |
|
Manufacturer Narrative
|
|
D10: section d information references the main component of the system.Other relevant device(s) are: product id: b3300542, serial#: (b)(6), implanted: (b)(6) 2023, explanted: (b)(6)2023, product type: lead; product id: b3300542, lot# serial#: (b)(6), implanted: (b)(6) 2023, explanted: (b)(6) 2023, product type: lead; product id: b31040, lot#: 082n32022a, product type: screening device; product id: b31040, lot#: 082n15823, product type: screening device; product id: b3300542m, serial#: (b)(6), implanted: (b)(6) 2023, product type: lead; product id: 3550-68, lot#: 0224899013, product type: screening device; product id: 3389-40, lot#: va2mxdg, implanted: (b)(6) 2023, product type: lead.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.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Event Description
|
|
Additional information was received reporting that fhc cannula was used.Impedance data indicated "high".Additional clarification regarding the troubleshooting performed included that the assistant hcp decided to test the three leads with the issues, but they didn't rotate the lead testing cable around the lead and made a vertical movement with the lead testing cable, making friction on the lead.As a result, the connectivity test was ok for the three leads.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Manufacturer Narrative
|
|
H3: analysis of the leads (serial #: (b)(6) and serial #: (b)(6) revealed no anomalies with the device and passed all labo ratory testing.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.
|
| |
|
Search Alerts/Recalls
|
|
|
