MAUDE Adverse Event Report: MEDTRONIC FABRICATION S.A.S. STREAMLINE TEMPORARY PACING LEADS; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6492F

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.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

Medtronic received information that on the same day post implant of this temporary pacing lead, the lead broke.It was reported that the lead broke and wire in the remaining portion was able to be connected to the temporary pacemaker cable to get it to function.The broken portion of the lead still exited the patient, so it was successfully retrieved.It was reported that patient anatomy did not contribute to the pacing lead breakage.The lead was explanted 11 days post implant.It is stated that staff are experienced in the use of this pacing lead.No intervention or adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination confirmed fracture of the conductor wire at 295 mm distal from the connector pin.The review of the returned product did not permit to identify a root cause for these fractures, this lead received an extra mechanical stress which conducts to fracture that conductor approximately in the middle of the lead body.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The fracture then most probably occurred due to fatigue related to flexing with the distal electrode, in combination with, but not limited to, the position of the electrode in the heart tissue, patient tissue condition, loss of implant location (dislodgement), the implant technique, or disconnection by patient movement.The instructions for use (ifu) for this product model indicates as precautions that ¿excessive bending, kinking, twisting or stretching may damage the junctions, pacing lead body and insulation resulting in device failure and/or loss of therapy¿.H3: device evaluated? updated h6: coding updated 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.

• Brand Name: STREAMLINE TEMPORARY PACING LEADS
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC FABRICATION S.A.S.; 103 route d anor; fourmies nord 59610 ; FR 59610
• Manufacturer (Section G): MEDTRONIC FABRICATION S.A.S.; 103 route d anor; fourmies nord 59610 ; FR 59610
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17245848
• MDR Text Key: 318657595
• Report Number: 9611350-2023-00006
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6492F
• Device Catalogue Number: 6492F
• Device Lot Number: BBD299206F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1