MAUDE Adverse Event Report: A&E MEDICAL CORPORATION UFM W 16MM 3/8CIR 64MM KN 24PK; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D2: device product code: ldh.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It is reported that the patient underwent a cardiac procedure, and temporary pacing wires were placed.Atrial leads frayed and fractured off at the end of the metal piece; therefore, pacing was lost.The ct physician's assistant (pa) stripped wire to directly expose and place back into the temporary pacemaker as a temporary solution.The pa had needed to strip further at least one other time.The ventricular leads are intact, but tenuous and appear as though they could fracture at any point in time.The permanent leads have already been placed with surgical plan to expose permanent pacing leads and place permanent pacemaker.The surgery date has been moved up four days.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, g3, g6, h2, h4, h6 and h10.Corrections are in sections: a1, a2, a3, a4, a5, e1, and e3.A4:patient weight: 3.166 kg ((b)(6) 2023), 3.502 kg ((b)(6) 2023).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D2: device product code: ldf.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.The reported event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, d4, e1, e3, g3, g6, h2, h6 and h10.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D2: device product code: ldf review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h4, h6, and h10.Corrections are in sections b1, d2, d4, and h1.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: UFM W 16MM 3/8CIR 64MM KN 24PK
• 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: 17278263
• Report Number: 0002242056-2023-00019
• Device Sequence Number: 17035809
• Product Code: LDF
• UDI-Device Identifier: 10841291100263
• UDI-Public: (01)10841291100263(10)03363(17)271001
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K803086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/16/2024
• 2 Devices were Involved in the Event: 1 2

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: N/A
• Device Catalogue Number: 024-311
• Device Lot Number: 03363
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 07/24/2023; 08/23/2023; 10/04/2023; Not provided
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/17/2023; 08/22/2023; 09/18/2023; 11/01/2023; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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: 1 MO
• Patient Sex: Female
• Patient Weight: 4 KG
• Patient Race: White