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

Model Number	407452
Medical Device Problem Codes	High Capture Threshold (3266); Unstable Capture Threshold (3269)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/03/2018
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 the right ventricular (rv) lead had high and variable thresholds.When the lead was programmed unipolar, the patient could feel the pacing.The lead remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that programming changes were made to adjust the output and turn off adaptive capture.

• 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 6; SG 486056
• MDR Report Key: 7551642
• Report Number: 3008973940-2018-01231
• Device Sequence Number: 274845
• Product Code: DTB
• UDI-Device Identifier: 00643169448940
• UDI-Public: 00643169448940
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P830061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: 10/07/2019
• Device Model Number: 407452
• Device Catalogue Number: 407452
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/06/2018
• 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: ADDR01 IPG, 457445 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR