MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 97800 |
Device Problems
Migration or Expulsion of Device (1395); Difficult to Remove (1528); Patient Device Interaction Problem (4001)
|
Patient Problems
Scar Tissue (2060); Device Embedded In Tissue or Plaque (3165)
|
Event Date 09/28/2023 |
Event Type
Injury
|
Event Description
|
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the patient was hit by grocery cart which caused lead to come "unhooked ," and patient required replacement surgery.The surgery was on (b)(6) 2023 and caller stated during that procedure the surgeon was unable to remove the entire lead and left a fragment behind.Caller wanted agent to confirm lead fragment in drs.Agent reviewed drs information and suggested caller have patient put device into mri to confirm scanning eligibility and refer to notes in patient's chart if necessary.Caller also indicated they may get an x-ray.
|
|
Manufacturer Narrative
|
Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va2r1u3); product type: 0200-lead.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 patient.When asked about the cause of the inability to remove the lead they stated that the doctor had told their husband it was due to scar tissue.When asked what steps would be taken to resolve the issue they stated they did not known, but it caused a huge problem for their lumbar mris.It needed to be removed as they were having terrible problems with their back.When asked about the status of the device they stated that they gave it to the manufacturing company on the day of their surgery.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|