MAUDE Adverse Event Report: MEDTRONIC, INC. CABLE 5846V DISP 6FT STER ROHS 5PK; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	5846V
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was a second event with the edwards swan ganz pacer catheter and the medtronic 5846v pacer cable whereby they do not stay connected.The bedside rn was aware of the first event and so the nurse taped the wires into the adapter port when they noticed the wires/prongs were not staying in place.Fortunately the patient did not need pacing and maintained a native rhythm.In follow up, contact was made with the medtronic representative.Representative sent a few instructions for use and our nurse specialist and representative met via teams video and nurse demonstrated the pacer cable, edwards cable and the issue of poor connection.Discussion is underway with medtronic and edwards regarding the use of adapter pins.These adapter pins are called dinapt and can be ordered and used on the catheters to it into the reusable cables (5492vl and 5492al).More follow up on the adaptor will be done.(when we called in an order for the current disposable cable, 5846v, we learned that this has been discontinued and that all epg products have gone away from the 6 ft length to the 12 ft length.).

• Brand Name: CABLE 5846V DISP 6FT STER ROHS 5PK
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MEDTRONIC, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13927981
• Report Number: 13927981
• Device Sequence Number: 20410574
• Product Code: LWP
• UDI-Device Identifier: 00643169307384
• UDI-Public: 00643169307384
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2022
• Report Date (Section F): 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5846V
• Device Catalogue Number: 5846V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 03/17/2022