MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6495

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.User facility report number (b)(4).

Event Description

Medtronic received information that one day post implant of this temporary pacing lead, the patient went into asystole for approximately 40 seconds and lost consciousness.A nurse discovered that the pin on the pacing lead broke or dislodged from the pod 1 on the temporary generator, which was believed to have caused the asystole.When the lead was attempted to be placed back into the connector, it was found to be too short due to the break.The nurse manually held the wire in the connector for approximately 15 minutes until the electrophysiology (ep) physician arrived.The physician adjusted the lead and secured it with tape.The lead remained in use and functional until it was explanted the next day.The patient did not receive any medication, cardiopulmonary resuscitation (cpr)or chest compressions during the period of asystole.When the temporary pacing lead was explanted, the patient received a permanent pacemaker, which was part of the planned treatment prior to the valve surgery.No additional adverse patient effects were reported.The physician indicated that it was uncertain if the cause of the break was that the pin was not fully inserted into the pod or if it was over tightened once it had been placed.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the visual examination confirmed the fracture of the anode connector pin approximately 10 mm from the distal connector edge.The round body of the connector pin broken area shows a depression which could indicate an overtightening of the connector pin in the extension cable connector or be a result of a stress bend on the connector pin which was not inserted fully into the connector.If the lead was not fully inserted, the fracture could had occurred during patient movement.The root cause for the fracture is likely unexpected handling of the lead connector pin while connected in the extension cable.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: BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8392043
• MDR Text Key: 137875802
• Report Number: 2025587-2019-00816
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K171253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6495
• Device Catalogue Number: 6495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR
• Patient Weight: 89