MAUDE Adverse Event Report: MPRI CAPSURE SP NOVUS LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	559453
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 6947m62 lead implanted on (b)(6) 2012.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 exhibited undersensing during atrial tachycardia/atrial fibrillation (at/af) episodes.The ra lead remains in use. no patient complications have been reported as a result of this event.

• Brand Name: CAPSURE SP NOVUS LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14683673
• Report Number: 2649622-2022-11405
• Device Sequence Number: 17414344
• Product Code: DTB
• UDI-Device Identifier: 00613994250223
• UDI-Public: 00613994250223
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P850089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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: 05/06/2013
• Device Model Number: 559453
• Device Catalogue Number: 559453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/14/2022
• Date Device Manufactured: 06/03/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 429888 LEAD, DTMB1QQ CRT-D
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 89 KG