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

Model Number 88862589-63

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

Patient Problems Cardiac Arrest (1762); Death (1802); No Code Available (3191)

Event Date 07/03/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter post operative a coronary artery bypass grafting, there were no post operative complications, readying for discharge the epicardial pacing wire were pulled and the patient immediately suffered cardiac arrest and did not recover despite chest re-entry and open cardiac massage immediately after arrest.

• Brand Name: FLEXON
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8876491
• MDR Text Key: 153781767
• Report Number: 9612501-2019-01530
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10884521103733
• UDI-Public: 10884521103733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88862589-63
• Device Catalogue Number: 88862589-63
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2019
• 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: 83 YR
• Patient Weight: 91