MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6495J

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: no product was returned.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Only month and year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that one to three days post valve replacement, while removing this temporary pacing lead, pacing was stopped and the extracorporeal pacemaker was removed.A break was noticed on the metal portion of the lead which was sandwiched in a crocodile clip in the extracorporeal pacemaker.There was no problem during use and there was no impact on the patient as the patient was not pacemaker dependent.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the microscopic inspection of the returned piece confirmed the fracture of the connector pin 16 mm from the proximal connector edge.No further analysis could be completed as the other section of the connector pin and the entire lead was not returned.No product identification was provided so the device history record could not be reviewed.The root cause for the fracture is assigned to unexpected handling of the lead connector pin while clamping or removing the lead which was sandwiched in a crocodile clip in the extracorporeal pacemaker.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: MEDTRONIC
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8461411
• MDR Text Key: 140222352
• Report Number: 2025587-2019-01062
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K012460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6495J
• Device Catalogue Number: 6495J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening