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

Model Number 6500F

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Note: this event was previously reported via regulatory rep #: 2025587-2020-03883.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this temporary pacing lead, cardiac tamponade was reported due to a right ventricle (rv) perforation from the lead.The perforation was repaired and no additional adverse patient effects were reported. .

• Brand Name: TEMPORARY PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11587105
• MDR Text Key: 242907272
• Report Number: 2025587-2021-00982
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6500F
• Device Catalogue Number: 6500F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR