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

Model Number 694765

Device Problems Mechanical Problem (1384); Cut In Material (2454); Decreased Sensitivity (2534); Connection Problem (2900)

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

Event Date 03/15/2017

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.

Event Description

It was reported that the right ventricular (rv) lead exhibited chronic low r-waves.The lead was capped and replaced.During the change-out procedure, the superior vena cava (svc) pin of the right ventricular (rv) lead would not come out of the implantable cardioverter defibrillator (icd) header.Three different wrenches were used but the setscrew was unable to be engaged.The physician observed a lot of material in the grommet and had to cut the svc pin off.The svc pin was left within the header of the device and the icd was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: SPRINT QUATTRO SECURE
• 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: 6628046
• MDR Text Key: 77177511
• Report Number: 2649622-2017-07068
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2012
• Device Model Number: 694765
• Device Catalogue Number: 694765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Date Device Manufactured: 02/08/2010
• 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-0475-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR