MAUDE Adverse Event Report: COV LP/LLC, AUGUSTA ANALYZER CABLE; PROGRAMMER, PACEMAKER

Model Number	2292
Medical Device Problem Codes	Signal Artifact/Noise (1036); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
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 analyzer cables showed noise on the ventricular channel after sterilization.The cable was returned for analysis.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the cable failed a ventricular negative continuity test.The issue was attributed to a bent pin in the cable plug.No other issues were identified.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ANALYZER CABLE
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): COV LP/LLC, AUGUSTA; 1647 perkins rd; augusta GA 30913
• MDR Report Key: 7673875
• Report Number: 1018120-2018-00124
• Device Sequence Number: 2770924
• Product Code: KRG
• UDI-Device Identifier: 00643169703247
• UDI-Public: 00643169703247
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 2292
• Device Catalogue Number: 2292
• Device Lot Number: 2292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/02/2018; 10/02/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1