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

Model Number	407458
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	09/20/2018
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 by the patient that the patient experienced bradycardia three days post implant and it was discovered that a lead was not "attached".Upon follow-up with the patient's following physician, it was indicated that the right ventricular (rv) lead had high thresholds.It was noted that a chest x-ray revealed the rv lead had a loss of slack and a microdislodgement was suspected.The rv lead was planned to be revised and 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.
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed no anomalies were found.Correction: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the right ventricular (rv) lead was explanted and replaced.

• 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: 8074191
• Report Number: 3008973940-2018-02287
• Device Sequence Number: 2262332
• Product Code: DTB
• UDI-Device Identifier: 00643169448957
• UDI-Public: 00643169448957
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2019

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: 11/08/2019
• Device Model Number: 407458
• Device Catalogue Number: 407458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 11/15/2018; 12/05/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 11/20/2018; 01/28/2019
• 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: A2DR01 IPG, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR