MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION WIRE 6500F TEMP HEARTWIRE; HEART-VALVE, MECHANICAL

Model Number 6500F

Device Problems Pacing Problem (1439); Failure to Sense (1559); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Date of event: only month and year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that an unknown duration post implant of this temporary pacing lead, the lead was providing "inappropriate" stimulation and "tracing", with no clinical signal identified from the lead.The biomedical department tested the generator and confirmed it was functioning as expected.The lead was replaced.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Upon receipt at medtronic¿s quality laboratory, visual examination confirmed insulation damage, which certainly could contribute to inappropriate stimulation.The root cause for the insulation damage appears to be due to handling of the lead conductor wire which had been damaged by a sharp point.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: WIRE 6500F TEMP HEARTWIRE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8448741
• MDR Text Key: 139725476
• Report Number: 2025587-2019-01017
• Device Sequence Number: 1
• Product Code: LWQ
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2020
• Device Model Number: 6500F
• Device Catalogue Number: 6500F
• Device Lot Number: DAB166306F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 06/14/2019; 10/17/2019
• Supplement Dates FDA Received: 06/19/2019; 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention