MAUDE Adverse Event Report: RICE CREEK MFG 5 MM BIFURCATED BIPOLAR LEAD OR TWO 5 MM UNI LEADS TO IS-1 BIPOLAR IPG ADAPTOR; ADAPTOR, LEAD, PACEMAKER

Model Number	5866-24M
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2018
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 pacing lead was exhibiting noise.The lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: 5 MM BIFURCATED BIPOLAR LEAD OR TWO 5 MM UNI LEADS TO IS-1 BIPOLAR IPG ADAPTOR
• Common Device Name: ADAPTOR, LEAD, PACEMAKER
• Manufacturer (Section D): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• MDR Report Key: 7970093
• Report Number: 6000030-2018-00085
• Device Sequence Number: 1214070
• Product Code: DTD
• UDI-Device Identifier: 00681490136785
• UDI-Public: 00681490136785
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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: Lay User/Patient
• Device Expiration Date: 12/28/2011
• Device Model Number: 5866-24M
• Device Catalogue Number: 5866-24M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR