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

Model Number 694965

Device Problems Fracture (1260); High impedance (1291); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2016

Event Type  Injury  

Manufacturer Narrative

This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.Concomitant medical product: dtbb1d1 icd, implanted: (b)(6) /2016.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right ventricular (rv) lead alerted for high superior vena cava (svc) coil impedance.The lead remained in use until it was further reported that the svc coil had fractured and there was an insulation breach.The svc portion of the lead was programmed off, and the lead was later explanted and replaced.The patient is a participant in the wrap-it study.No 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7486317
• MDR Text Key: 107325268
• Report Number: 2649622-2018-07619
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2007
• Device Model Number: 694965
• Device Catalogue Number: 694965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Date Device Manufactured: 04/04/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0070-2008
• Patient Sequence Number: 1
• Treatment: 419488 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 99