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

Model Number 6492F

Device Problems Failure to Sense (1559); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 05/08/2023

Event Type  Injury  

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.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

Medtronic received information that during the use of a temporary pacing lead, the pacing lead failed to sense.It was reported that there were issues with the a wires and a threshold check was performed once the patient stabilized.The pacer settings were ddi mode, atrial and ventricular milliamps set at 10, and sensitivity was set to 0.4 millivolts (mv) for atria and 0.8 mv for ventricle.It was reported that the patient initially had a heart rate of 60 beats per minute (bpm) and "the pacer" was slowly "turned  up" to pace above intrinsic rhythm when the issue occurred.It was noted that the patient¿s intrinsic rhythm was a normal sinus rhythm in the 70s bpm.It was reported that this resulted in an "r on t event" occurring and the patient developed ventricular tachycardia and had to be coded.The patient subsequently regained consciousness.It was also noted that the patient had developed ventricular fibrillation (vf) during this time.It was mentioned that staff are familiar in the use of this model of pacing lead.No additional adverse effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed, that the lead was received with a knot attached to the patient¿s lead.Purple insulation damage was observed, on the lead.The surgeon elected to place a knot to tie both conductor wires, during implant surgery.There is no signal, that this is a cause for the lead insulation damage.As it is far away of the damage, nevertheless this knot may be considered, as a misuse of the device.Per, instructions for use.The review of the returned product did not permit to identify a root cause.This lead received an extra mechanical stress, which conducts to insulation damage.Which, 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.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: 17181048
• MDR Text Key: 317639547
• Report Number: 9611350-2023-00004
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00643169310087
• UDI-Public: 00643169310087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6492F
• Device Catalogue Number: 6492F
• Device Lot Number: BAC357207F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• 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 Outcome(s): Required Intervention; Life Threatening