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

Model Number	407452
Medical Device Problem Codes	Intermittent Capture (1080); Capturing Problem (2891); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
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 a few weeks post implant, the right ventricular (rv) lead exhibited increasing to high thresholds.There was intermittent capture at maximum output in both unipolar and bipolar pacing.Review of a fluoroscopy could not confirm if the lead had moved since there was no previous x-ray, however a dislodgement was suspected.The physician chose to remove the lead and replace it with an active fixation lead.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed, no anomalies were found.Visual analysis of the lead indicated apparent ex-plant damage.If information is provided in the future, a supplemental report will be issued.

• 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: 7607309
• Report Number: 3008973940-2018-01365
• Device Sequence Number: 11186204
• Product Code: DTB
• UDI-Device Identifier: 00643169448940
• UDI-Public: 00643169448940
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/14/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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: W3DR01 IPG, 507645 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR