MAUDE Adverse Event Report: MEDTRONIC, INC.; PROGRAMMER, PACEMAKER

Model Number	6177
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/18/2018
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 when a new box of sterile radiofrequency (rf) head sleeves was opened in the catheterization laboratory, it was noted that the first packet had an elastic band within the packaging.The product was returned for analysis.There was no patient involvement.
Additional Manufacturer Narrative
Product analysis: a sterile sleeve was received in sealed packaging for analysis.A foreign object was noted inside the sealed bag.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NA
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7414952
• Report Number: 2182208-2018-00453
• Device Sequence Number: 1446475
• Product Code: KRG
• UDI-Device Identifier: 10681490142653
• UDI-Public: 10681490142653
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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 Expiration Date: 10/21/2022
• Device Model Number: 6177
• Device Catalogue Number: 6177
• Device Lot Number: D0349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1