MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD FLEXON; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 88862592-43

Device Problems Break (1069); Product Quality Problem (1506); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during an open cardio surgical treatment in a child, there was too soft material of the electrode made it impossible to bend it into a hook for sewing purposes.The needle broke.It was noted that the needle that was used to pass through the coatings had no incision so that it can be easily broken.It was necessary to use an orthopedic cutter, it was noted the other tool got damaged and not cut the needles.There was no patient injury.

Event Description

According to the reporter, during an open cardio surgical treatment in a child, there was too soft material of the electrode made it impossible to bend it into a hook for sewing purposes.The straight needle bent into a hook as it passed through the skin.The surgeon broke the needle to use it as an electrode had to cut it with the knife.It was noted that the needle that was used to pass through the coatings had no incision so that it can be easily broken.It was noted the other tool got damaged and not cut the needles.The user will try to replace the product with a more convenient one for use to resolve the issue.There was no patient injury.

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.

Manufacturer Narrative

New information has been received, and reassessment of the complaint found that it is no longer a reportable issue.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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

According to the reporter, during an open cardio surgical treatment in a child, there was too soft material of the electrode that made it impossible to bend it into a hook for sewing purposes.The straight needle bent into a hook as it passed through the skin.To connect the electrode, the surgeon had to break it, and since it was not break away, the surgeon had to use an orthopedic cutter.It was noted that the needle that was used to pass through the coatings had no incision so that it can be easily broken.The other tool got damaged and did not cut the needles.The user will try to replace the product with a more convenient break away needle for use to resolve the issue.There was no patient injury.

• Brand Name: FLEXON
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12647940
• MDR Text Key: 276894372
• Report Number: 9612501-2021-01713
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10884521103757
• UDI-Public: 10884521103757
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K955722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88862592-43
• Device Catalogue Number: 88862592-43
• Device Lot Number: D1D3494Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 10/21/2021; 11/30/2021
• Supplement Dates FDA Received: 11/07/2021; 12/15/2021
• Date Device Manufactured: 04/28/2021
• 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