MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97715 |
Device Problems
Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
|
Patient Problems
Pain (1994); Insufficient Information (4580)
|
Event Date 07/06/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from multiple sources (healthcare provider, clinical study, manufacturer representative) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient experienced pocket pain and it disturbed her.The doctor examined and saw the scar was calm on (b)(6) 2020.There was possibly the upper part of the device was "close as stick of the scar" but no sign of infection.The pocket pain was due to implant procedure.Neurotol patch was prescribed on (b)(6) 2020.It was observed that when she was standing the device puts itself horizontal in the belly.The doctor examined her on (b)(6) 2020 and the pain was less than before so decided to let it and wait and see.As she had pain on her left side and no operation will be done, decided to introduce and test a second lead and connect it on this device which is "reposition" on this intervention.Additional information was received reporting the second lead was connected when the ins was repositioned on (b)(6) 2021.The outcome was ongoing as of (b)(6) 2021.
|
|
Event Description
|
Additional information received reported that the cause was unknown.It was noted that it was possibly the upper part of the device was stuck to the scar.
|
|
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 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 from the health care provider (hcp) of a clinical study reporting that the outcome was resolved without sequelae on (b)(6) 2021.
|
|
Search Alerts/Recalls
|
|
|