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

Model Number 6949

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Anxiety (2328); Distress (2329); Depression (2361)

Event Date 11/16/2005

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right ventricular lead malfunctioned.The lead was attempted to be repositioned when the pacing impedance was noted to be lower than 300 ohms which was suggestive of a fracture.The lead was explanted and replaced.The patient is part of a lawsuit alleging that the lead is inherently defective and that the patient may have suffered damages and losses including, but not limited to: emotional distress, including mental distress, anger, depression and anxiety.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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7588415
• MDR Text Key: 110662248
• Report Number: 2649622-2018-09776
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2007
• Device Model Number: 6949
• Device Catalogue Number: 6949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• Date Device Manufactured: 05/13/2005
• 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
• Patient Outcome(s): Hospitalization; Required Intervention