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

Model Number	88862589-63
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); No Code Available (3191)
Date of Event	07/03/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 8876491
• Report Number: 9612501-2019-01530
• Device Sequence Number: 19362877
• Product Code: LDF
• UDI-Device Identifier: 10884521103733
• UDI-Public: 10884521103733
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K955722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 88862589-63
• Device Catalogue Number: 88862589-63
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR
• Patient Weight: 91