MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT

Model Number	407658
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
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 during the implant procedure, the lead helix was taken out of the package and exercised prior to being placed in the body.Once placed and before the helix was extended, the signal obtained looked non-physiologic and "noisy".Occasional deflections would appear amidst the noisy baseline and seemed to line up with surface qrs complexes.Recognizing that the helix was still retracted, and that the anatomical location was desirable, the physician extended the helix in the usual fashion to affix it to the cardiac tissue.At this point, the noisy baseline was gone, and clear rv electrograms were noted.Desiring larger r-waves, the physician retracted the helix once again and then placed it on the rv septum where r-waves were larger.The helix was once again deployed for the final time and sensing/impedance/thresholds remained stable throughout the case.The lead was left in the final position and remains in use.No patient complications have been reported as a result of this event.

• Brand Name: CAPSUREFIX NOVUS
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• MDR Report Key: 7417835
• Report Number: 3008973940-2018-00661
• Device Sequence Number: 1083729
• Product Code: DTB
• UDI-Device Identifier: 00763000014650
• UDI-Public: 00763000014650
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: 11/06/2019
• Device Model Number: 407658
• Device Catalogue Number: 407658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR