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	Arrhythmia (1721); Death (1802); Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452); Loss Of Pulse (2562); No Code Available (3191)
Date of Event	05/20/2019
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 coronary artery bypass grafting on the 5th day when the patient was being readied to be discharged and the epicardial pacing wires were discontinued, shortly thereafter the patient complained of not feeling well and became diaphoretic.Hypotension also developed post-wire removal and cardiac rhythm change noted as well.The patient was pulseless and advance cardiac life support was initiated, pulse returned and patient was transferred to the intensive care unit, where his chest was opened and epinephrine was directly delivered to the heart.The patient was taken to the operating room and washed out/closed chest and returned to the intensive care unit where he was later diagnosed with anoxic brain injury.Care was withdrawn in collaboration with the family.

• Brand Name: FLEXON
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8883534
• Report Number: 9612501-2019-01531
• Device Sequence Number: 16734706
• 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): 08/12/2019

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: 08/12/2019
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 105