MAUDE Adverse Event Report: MEDTRONIC, INC ZINGER MEDIUM; OCCLUDER, CATHETER TIP

Model Number LVZRMS180S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Electro-Mechanical Dissociation (1826); Ventricular Fibrillation (2130); Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 04/04/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that during implant, the guidewire perforated the coronary sinus, leading to pericardial effusion and subsequent cardiac tamponade.A pericardiocentesis was performed and a sternotomy was performed to start to repair the coronary sinus.The patient then went into ventricular fibrillation (vf) with subsequent electromechanical dissociation.The patient was externally defibrillated but ultimately died.The primary cause of death was repeated vf.The patient was a participant in the electrocardiogram (ecg) belt for cardiac resynchronization therapy response clinical study.No further information was reported.

Manufacturer Narrative

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

• Brand Name: ZINGER MEDIUM
• Type of Device: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8545157
• MDR Text Key: 142929044
• Report Number: 1220452-2019-00050
• Device Sequence Number: 1
• Product Code: DQT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K983927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LVZRMS180S
• Device Catalogue Number: LVZRMS180S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2019
• 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): Death
• Patient Age: 75 YR
• Patient Weight: 70