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

Model Number 6495

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that this pacing wire fractured at a point past the coiled segment of wire.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: no electrical verification has been performed as only sections of products have been returned.The analysis of the returned products pieces confirms in both case the fracture of the inner conductor wire at the proximal edge of the small distal electrode.Both leads received extra handling as they both get a knot and have been separated from the proximal section.Conclusions: due to the lack of product identification the analysis cannot include a review of the device history record.The review of the returned product did not permit to identify a root cause for fracture.The fracture then most probably occurred due to fatigue related to flexing with the distal electrode, in combination with, but not limited to, dislodgement, the position of the electrode in the heart tissue, the implant technique and the implant time.Updated data: h.3: device evaluated? h.6: coding d.9: device available for evaluation? 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: 16185133
• MDR Text Key: 307708225
• Report Number: 9611350-2023-00002
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6495
• Device Catalogue Number: 6495
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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