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

Model Number	407658
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Codes	Syncope (1610); Cardiac Arrest (1762); Fall (1848)
Date of Event	03/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that approximately one day post system implant, the patient experienced a syncopal episode with cardiac arrest on telemetry.The patient had injuries to his face as a result.The implantable pulse generator (ipg) was later evaluated and the capture threshold and impedance were within normal limits.The right ventricular (rv) lead exhibited loss of capture that could not be replicated.The patient was evaluated again, and the rv lead checked through the device and the analyzer and appeared to be functioning normally.The physician suspected a micro-fracture of the rv lead.The rv lead was explanted and replaced with another of the same lead.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned, analyzed, and no anomalies were found.The distal low voltage electrode of the lead was covered in body tissue/fibrotic growth.If information is provided in the future, a supplemental report will be issued.

• 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 ; SG 48605
• MDR Report Key: 7464928
• Report Number: 3008973940-2018-01002
• Device Sequence Number: 10789296
• Product Code: DTB
• UDI-Device Identifier: 00763000014650
• UDI-Public: 00763000014650
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/05/2019
• Device Model Number: 407658
• Device Catalogue Number: 407658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: W1DR01 IPGL, 407652 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 100