|
Model Number B3301542M |
Device Problems
Human-Device Interface Problem (2949); Manufacturing, Packaging or Shipping Problem (2975); Insufficient Information (3190)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/23/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id b35200, lot# , serial# (b)(4), implanted: , explanted:.Product type: implantable neurostimulator.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
|
It was reported that the surgeon was accidentally given the wrong size lead, 1.5 mm spacing, versus desired.5 mm spaced lead.The lead was implanted.Upon post-op x-ray imaging, the mistake was identified.After consulting the family, it was decided to explant the lead and implant the correct size, which was done so the same day.The issue was resolved.Additional information was received from the manufacturer representative (rep).The lead was explanted because it was the wrong size and the new.5mm lead was then implanted.No symptoms experienced.This information was confirmed with the physician.
|
|
Event Description
|
Additional information was received from a healthcare provider (hcp) and company representative (rep), noting that the hcp would like to submit a request to update the verbiage on the packaging of the lead kit.It was further reported that the rep believed our boxes were not clearly indicating which lead, which was why a wrong lead was opened and implanted, only to be explanted the same day and the right lead was implanted.It appeared that a customer implanted the wrong lead after missing or misreading the model number on the box.
|
|
Manufacturer Narrative
|
B1 and b2 fields were updated/corrected.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.
|
|
Search Alerts/Recalls
|
|
|