MAUDE Adverse Event Report: MPRI ATTAIN ABILITY STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number	439678
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 383069, lead, implanted: (b)(6) 2014; 383059, lead, implanted: (b)(6) 2017.If information is provided in, the future, a supplemental report will be issued.
Event or Problem Description
It was reported that an infection occurred.The cardiac resynchronization therapy pacemaker (crt-p) system was explanted and replaced.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY STRAIGHT MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 10079267
• Report Number: 2649622-2020-09767
• Device Sequence Number: 3852355
• Product Code: OJX
• UDI-Device Identifier: 00613994719096
• UDI-Public: 00613994719096
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/29/2017
• Device Model Number: 439678
• Device Catalogue Number: 439678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/21/2020
• 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: C4TR01 CRT-P
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR