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	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came in with 3rd degree block and needed a transvenous catheter.Edwards swan ganz pacer catheter ref d9120fs does not stay connected to our new pacer cables from medtronic 5846v.The connection is not secure and likely more of the pacer cable issue since this is new.The bedside rn needed to manually hold the two connections together in order to keep electricity for the patient so they would continue to pace all the way to the cath lab until they received a new pacer.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: 13927953
• Report Number: 13927953
• Device Sequence Number: 11203514
• 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): 03/10/2022
• 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?: No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 03/17/2022