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

Model Number	457445
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: dtma1d4 icd; 383069 lead, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that one day post replacement procedure, the right atrial (ra) lead had no capture.It was noted that a chest x-ray revealed the ra lead dislodged.During lead revision, after the lead was revised the physician went to reattach the lead into the header and the wrench would not engage into the set screw.The physician could not screw the lead back into the set screw.The device was explanted and replaced, and the ra lead was explanted and replaced.No patient complications have been reported as a result of this event.

• Brand Name: CAPSURE SENSE LEAD MRI SURESCAN
• 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: 8633662
• Report Number: 3008973940-2019-01503
• Device Sequence Number: 19246363
• Product Code: DTB
• UDI-Device Identifier: 00643169410954
• UDI-Public: 00643169410954
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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: 11/06/2019
• Device Model Number: 457445
• Device Catalogue Number: 457445
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/22/2019
• 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: 7122Q LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR