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

Model Number 694965

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Emotional Changes (1831); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

The initial reported event of defective product/injuries was previously submitted via a remedial action exemption (rae) summary report.The manufacturer has voluntarily discontinued this rae, so supplemental information is being submitted via a 30 day report.Concomitant medical products: product id: 5076-52 lead, implanted: (b)(6) 2006.Evaluation summary: the full lead was returned in segments, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.

Event Description

The initial reported event of defective product/injuries was previously submitted via a remedial action exemption (rae) summary report.The manufacturer has voluntarily discontinued this rae, so supplemental information is being submitted via a 30 day report.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: 10687764
• MDR Text Key: 211638800
• Report Number: 2649622-2020-19975
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/25/2007
• Device Model Number: 694965
• Device Catalogue Number: 694965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2005
• 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: 7278 ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR