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

Model Number 6494

Device Problem Failure to Sense (1559)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/22/2021

Event Type  malfunction  

Event Description

Medtronic received information through a post market clinical follow-up survey on the medtronic streamline unipolar temporary myocardial pacing wire (model 6494).The healthcare professional completing this survey indicated that they had used this device 2 times during the previous 12 months.During that time, the following events occurred.The healthcare professional reported one instance of lead removal difficulties.This was reported to have an impact on the procedure but no clinical/patient impact.The healthcare professional reported one instance of lead dislodgement that had no impact on the procedure.The healthcare professional reported two instances where the pacing leads did not provide temporary postsurgical pacing and sensing for an implant duration of 7 days or less.One instance was reported to be related to the procedure but not directly to the temporary pacing lead.The other instance was reported to be related to the temporary pacing lead and bleeding was present.No unique device identifier numbers were provided.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

End date of survey results used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13114383
• MDR Text Key: 284965459
• Report Number: 9611350-2021-00007
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K012459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6494
• Device Catalogue Number: 6494
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• 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