MAUDE Adverse Event Report: MPRI CAPSURE FIX MRI; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number 5086MRI52

Device Problems Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products: 5086mri58 lead implanted on (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced suspected infection and pocket erosion.It was noted that the pacing leads were adhered to the vicinity of the superior vena cava.The leads were cut to reduce particles entering the patient.The implantable pulse generator (ipg) system was removed. no further patient complications have been reported as a result of this event.

• Brand Name: CAPSURE FIX MRI
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• 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: 13948103
• MDR Text Key: 288166984
• Report Number: 2649622-2022-05928
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P090013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2014
• Device Model Number: 5086MRI52
• Device Catalogue Number: 5086MRI52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Date Device Manufactured: 10/05/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: W2DR01 IPG
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 94 YR
• Patient Sex: Female