MAUDE Adverse Event Report: A&E MEDICAL CORPORATION MYO/WIRE ULTRA-THIN BIPOLAR INLINE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	N/A
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Device product code - ldf.(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the pacing wire that attaches to the patient's heart malfunctioned, resulting in 3 episodes of ventricular fibrillation after r on t phenomenon.Patient required cpr.Pacing cable was set as a backup rate of 50 while the patient had his own rhythm of 90.Despite this, the pacer paced the patient inappropriately and caused v-fib.Miliamps were set to 10ma milivolts set to 2.It was reported that no further information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The returned product was tested per inspection procedures.All tests yielded no fault found.The electrical conductivity was physically checked - there was no electrical conductivity between the flare electrode and the zig-zag electrode (a passing result).The insulation between wires was physically checked - electrical conductivity of wire was not present between wires (a passing result).During testing the returned product was tested and then re-positioned and re-tested.This was performed a total of three times for both the continuity and resistance checks.There were no changes in conductivity or varying results.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.No problem was found with the returned product.Product met inspection protocols.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: MYO/WIRE ULTRA-THIN BIPOLAR INLINE
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15824664
• Report Number: 0002242056-2022-00010
• Device Sequence Number: 20372743
• Product Code: LDF
• UDI-Device Identifier: 08718627412527
• UDI-Public: (01)08718627412527(10)03769(17)240601
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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 Expiration Date: 06/01/2024
• Device Model Number: N/A
• Device Catalogue Number: BMZF605ACBBG
• Device Lot Number: 03769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male