MAUDE Adverse Event Report: MPRI CAPSUREEPI; ELECTRODE, PACEMAKER, PERMANENT

Model Number	4968-35
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4968-60 lead, implanted (b)(6) 2016; 4968-35 lead, implanted (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that there was a lead integrity alert for high sensing integrity counter (sic) on the right ventricular (rv) lead and a non-sustained high rate episode.The rv lead remains 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 later reported that the rv lead had a suspected fracture and the cardiac resynchronization therapy defibrillator (crt-d) was also suspected of having a noise issue.The rv lead was capped and the crt-d was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
The additional information was previously submitted in regulatory report: 2649622-2018-10948.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was later reported that the high sic on the rv lead was due to oversensing of noise and the alerts continued to show on interrogation reports.

• Brand Name: CAPSUREEPI
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba,pr MN 00766
• MDR Report Key: 7526730
• Report Number: 2182208-2018-00946
• Device Sequence Number: 10869683
• Product Code: DTB
• UDI-Device Identifier: 00681490148733
• UDI-Public: 00681490148733
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2018

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: 02/10/2018
• Device Model Number: 4968-35
• Device Catalogue Number: 4968-35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 06/11/2018; 10/30/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 10/10/2018; 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR