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

Model Number 6495

Device Problem Break (1069)

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

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

Event Description

Medtronic received information that during the removal of this temporary pacing lead, the lead fractured and a portion of the lead remained inside the patient.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection revealed 2 partial products (in 3 pieces).The partial products of this case were named by convention here after p1, p2, p3.The first returned product (p1) was missing the distal end section including the distal electrode and a piece of blue monofilament.Proximal to the electrode ring remained a piece of conductor coaxial wire.268 mm proximally to the electrode, a knot was observed on the conductor wire; 20 mm further the conductor wire was cut.The second returned product section (p2) was as expected post-surgery, except the proximal section, where next to the electrode ring remained a piece of conductor coaxial wire 288 mm proximally to the electrode, a knot was observed on the conductor wire; 53 mm further the conductor wire was cut (figure 8).The distal section of p2 was as expected after the surgical operation.Both distal electrodes were present as per initial construction, and a distal piece of coiled blue monofilament (91mm) was available.One lead proximal (p3) with 52 mm of conductor wire was returned.It was expected that this section was constituent of one or the other returned distal piece.The connector pin junctions to the conductor wire were as expected per initial construction.The analysis of the returned products confirmed a fracture of the inner conductor wire at the proximal edge of the small distal electrode.Both leads received extra handling as they both had a knot and were separated from the proximal section.Conclusion: a device history record review could not be completed without the device lot identification.No electrical verification was performed as only sections of products were returned.The instruction for use for this device indicate that the physician may choose to vary the lead fixation procedure in accordance with judgment and experiences such the selected fixation method should always allow for later pacing lead removal, it also states do not excessively bend, kink, twist, or stretch the pacing lead.Excessive bending, kinking, twisting, or stretching may damage the junctions, pacing lead body and insulation resulting in device failure and / or loss of therapy.The fracture 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, dislodgement, the implant technique and the implant time.H6: coding updated d3: 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.

Manufacturer Narrative

Medtronic received additional information that the lead was implanted for 7 days prior to removal.It was reported this patient underwent coronary bypass grafting with mitral and tricuspid valve repair and a 'cox-maze iv' procedure.The patient required temporary pacing postoperatively and was severely bradycardic when not av paced.The patient went into atrial fibrillation, the temporary leads were removed, and a permanent pacemaker was implanted 7 days post procedure.Upon removal of the temporary pacing leads it was noted that there was a fracture of the lead just past the proximal electrode and a portion of the lead broke off and was retained in the patient.No additional adverse patient effects were reported.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 CA 59610 ; FR 59610
• Manufacturer (Section G): MEDTRONIC FABRICATION S.A.S.; 103 route d anor; fourmies nord CA 59610 ; FR 59610
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14266039
• MDR Text Key: 290535823
• Report Number: 2025587-2022-01237
• 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,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• 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: 09/01/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Male