MAUDE Adverse Event Report: RICE CREEK MFG PROGRAMMING HEAD; PROGRAMMER, PACEMAKER

Model Number	2067
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: analysis noted that the associated programmer would turn off when the radiofrequency (rf) head was plugged into the programmer.The issue was determined to be caused by an out of electrical specification rf head cable.This confirmed the initial complaint on the programmer was directly caused by the out of specification rf head.It was noted that the programmer functioned normally with a different rf head.Analysis also noted that the label of the rf head was delaminated.The cable and label of the rf head were replaced.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the radiofrequency programmer head originally returned as an associated device subsequently tested out of specification during manufacturer¿s analysis.There was no patient involvement.

• Brand Name: PROGRAMMING HEAD
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• MDR Report Key: 9722968
• Report Number: 6000030-2020-00027
• Device Sequence Number: 16233582
• Product Code: KRG
• UDI-Device Identifier: 00721902290121
• UDI-Public: 00721902290121
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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: Other
• Device Model Number: 2067
• Device Catalogue Number: 2067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1