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

Model Number 6949

Device Problems High impedance (1291); Decreased Sensitivity (2534); Impedance Problem (2950)

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

Event Date 05/12/2006

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the right ventricular (rv) lead was dysfunctional as superior vena cava (svc) coil impedance had risen to a high range and the lead was exhibiting low sensing values.The lead was explanted and replaced.Further information indicated that 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: 7588416
• MDR Text Key: 110665358
• Report Number: 2649622-2018-09765
• 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: 04/20/2008
• 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: 05/02/2006
• 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