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 Capture (1081)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5; d4; h2; h4; h6; h11.The reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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
It was reported the patient received atrial and ventricular epicardial wires during open heart surgery.Since the patient exited the operating room, the devices were having problems oversensing intermittently (pacer not pacing when supposed to).Patient was continuously paced because underlying rhythm is complete heart block with junctional escape rhythm.The surgeon was concerned if the external pacer was working on not, so the next day, the surgeon inserted a transvenous pacer (tvp) through the patient's right internal jugular cordis.The surgeon attempted several times to insert without luck.The surgeon decreased the sensitivity by increasing the mv to 4 (previously was at 2).This temporarily fixed the problem, and the patient was having less oversensing events, although still had some.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in canada.The 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 there was loss of capture associated with movement of a pacer wire.Due to an unstable underlying heart rhythm, a temporary ventricular pacemaker was inserted.The cable was changed and pacing subsequently worked without difficulty.The patient was then able to be mobilize.Attempts have been made and no further information has been provided.

• 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: 23982873
• Report Number: 0002242056-2026-00002
• Device Sequence Number: 11919737
• Product Code: IKD
• UDI-Device Identifier: 20841291105265
• UDI-Public: (01)20841291105265(10)28029(17)291101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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 Catalogue Number: 019-530
• Device Lot Number: 28029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown