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

Model Number N/A

Device Problem Pacing Problem (1439)

Patient Problem Ventricular Fibrillation (2130)

Event Type  Injury  

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 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 Description

No further event information available at the time of this report.

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
• Type of Device: 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
• MDR Text Key: 303907934
• Report Number: 0002242056-2022-00010
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 08718627412527
• UDI-Public: (01)08718627412527(10)03769(17)240601
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male