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

Model Number	407458
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
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 the right atrial (ra) lead and right ventricular (rv) lead exhibited high impedances post operatively.Follow up from the rep confirmed that the impedances were all within limits upon a manual interrogation and no intervention was needed on this patient.Both ra and rv leads remain in use.No 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 reported that the ra and rv leads exhibited undefined impedances.

• 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: 7974119
• Report Number: 3008973940-2018-02099
• Device Sequence Number: 13766970
• Product Code: DTB
• UDI-Device Identifier: 00643169448957
• UDI-Public: 00643169448957
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: Lay User/Patient
• Device Expiration Date: 11/08/2019
• Device Model Number: 407458
• Device Catalogue Number: 407458
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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 IPG, 457453 LEAD
• Patient Age: 85 YR