MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSURE SENSE; ELECTRODE, PACEMAKER, PERMANENT

Model Number	407452
Medical Device Problem Codes	Pacing Problem (1439); Under-Sensing (1661); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Codes	Syncope (1610); Bruise/Contusion (1754); Non specific EKG/ECG Changes (1817); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: product id: 5076-52 lead, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use of the right ventricular (rv) lead, the patient had multiple five second pauses.Evaluation revealed an increase in rv lead threshold.An x-ray confirmed that the rv lead had dislodged.The rv lead was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient had passed out and bruised their face and knees.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSURE SENSE
• 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: 7598815
• Report Number: 3008973940-2018-01344
• Device Sequence Number: 13485455
• Product Code: DTB
• UDI-Device Identifier: 00643169448940
• UDI-Public: 00643169448940
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830061
• 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): 06/27/2018

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: 11/07/2019
• Device Model Number: 407452
• Device Catalogue Number: 407452
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 86 YR