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

Model Number 694958

Device Problems Signal Artifact/Noise (1036); Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problems Discomfort (2330); Palpitations (2467); Shock from Patient Lead(s) (3162)

Event Date 09/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtba2d1 crt-d, implanted (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was noise on the ring electrode and a sudden increase in lead impedance on the right ventricular (rv) lead.It was noted that the rv lead had fractured.The patient experienced an inappropriate shock due to the noise and had palpitations and discomfort in the chest.The rv lead was reprogrammed and capped and replaced.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: 10575378
• MDR Text Key: 208191855
• Report Number: 2649622-2020-18286
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2020

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: 07/27/2008
• Device Model Number: 694958
• Device Catalogue Number: 694958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/23/2020
• Date Device Manufactured: 08/02/2006
• 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, 419378 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR