MAUDE Adverse Event Report: MEDTRONIC, INC. DISPOSABLE SAFETY PATIENT CABLE; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number	5846V
Medical Device Problem Codes	Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the health care professional had difficulty connecting a competitor's catheter to the patient pace cable.It was nearly impossible to connect and the force required to connect almost damaged the catheter pin.Another patient cable of the same lot was used along with a new catheter and it worked.The cable was discarded.No patient complications have been reported as a result of this event.

• Brand Name: DISPOSABLE SAFETY PATIENT CABLE
• Common Device Name: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10419599
• Report Number: 2182208-2020-01547
• Device Sequence Number: 2676473
• Product Code: LWP
• UDI-Device Identifier: 00643169431645
• UDI-Public: 00643169431645
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P820003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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 Expiration Date: 01/23/2022
• Device Model Number: 5846V
• Device Catalogue Number: 5846V
• Device Lot Number: 756740001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1