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

Model Number	2292
Medical Device Problem Codes	Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/11/2019
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 cable's clips do not close, preventing secure fixation of the lead.It was noted that the clips were not sterilized prior to being tested.The cables are expected to be returned for analysis.There was no patient involvement.
Additional Manufacturer Narrative
Product analysis: manufacturer's analysis confirmed the customer comment that the analyzer surgical cable¿s atrial clip did not close on its own.The cable was to be scrapped.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The cables were returned for analysis.

• Brand Name: ANALYZER CABLE
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8255155
• Report Number: 2182208-2019-00115
• Device Sequence Number: 19476758
• Product Code: KRG
• UDI-Device Identifier: 00721902307294
• UDI-Public: 00721902307294
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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: 995950001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1