MAUDE Adverse Event Report: MPRI SPRINT FIDELIS; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number 6949

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling (2091)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

Continuation of d11: ddbb1d1 icd, implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the implantable cardioverter defibrillator (icd) system was explanted due to infection.Vegetation on the right ventricular (rv) lead was observed along with redness and inflammation at the pocket site.Cultures were taken and antibiotics were administered.A new device system will be implanted in approximately a month.No further patient complications have been reported as a result of this event.

• Brand Name: SPRINT FIDELIS
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 10751967
• MDR Text Key: 213637179
• Report Number: 2649622-2020-20909
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6949
• Device Catalogue Number: 6949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Date Device Manufactured: 02/20/2007
• 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: 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 112