MAUDE Adverse Event Report: A&E MEDICAL CORPORATION DISPPATCBL 2.0 6FT W 8PK; CABLE, ELECTRODE

Catalog Number	019-530
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.D2: device product code: ikd.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 a patient experienced sensing failure during an urgent cath lab procedure.After swapping the pacing wires, and eventually swapping the patient cable, sensing was achieved.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h10 d2: device product code: ikd no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) 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 which would change or alter any conclusions or information, a supplemental 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 follow-up report is being submitted to relay additional information.Unknown product was returned for this complaint: upon review it was determined that the item returned from the reporter is not item# 019530 lot# 06498 as reported in the per and is not associated with any zimmer biomet products. further, no photographs of the affected devices were included in this complaint submission.As such, no definitive statements can be made regarding condition of the product.A definitive root cause cannot be determined.The reported event is unconfirmed.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: DISPPATCBL 2.0 6FT W 8PK
• Common Device Name: CABLE, ELECTRODE
• 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: 17458064
• Report Number: 0002242056-2023-00024
• Device Sequence Number: 19469254
• Product Code: IKD
• UDI-Device Identifier: 20841291105265
• UDI-Public: (01)20841291105265(10)06498(17)270901
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2024
• 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 Catalogue Number: 019-530
• Device Lot Number: 06498
• Was Device Available for Evaluation?: No
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 04/15/2024
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 12/27/2023; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown