MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE; DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 6947M55

Device Problem Invalid Sensing (2293)

Patient Problem Electric Shock (2554)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported that a right ventricular (rv) lead became dislodged, had t-wave oversensing (twos), and delivered an inappropriate shock.There was also indication of r-wave undersensing.The lead was explanted and replaced.No further patient complications were reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product event summary: the full lead was returned, analyzed and analysis was performed and no anomalies were found.The distal lv (low voltage) electrode of the lead was covered in blood.The lead was returned with blood on the helix and within the sleevehead.

Manufacturer Narrative

Performance data collected from the device was received and analyzed.Analysis of the device memory indicated rv (right ventricular) oversensing.Analysis of the device memory indicated rv (right ventricular) undersensing information.Analysis of the device memory indicated the unexpected delivery of a ventricular tachyrhythmia therapy.R wave undersensing has been confirmed.T wave over sensing has been confirmed.Unexpected shock has occurred on (b)(6) 2014.

Manufacturer Narrative

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

• Brand Name: SPRINT QUATTRO SECURE
• Type of Device: DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4676435
• MDR Text Key: 5642241
• Report Number: 2649622-2015-02702
• Device Sequence Number: 1
• Product Code: NVY
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2015
• Device Model Number: 6947M55
• Device Catalogue Number: 6947M55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2013
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00058 YR