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

Model Number 6947M62

Device Problems High impedance (1291); Device Contamination with Body Fluid (2317)

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

Event Date 02/23/2015

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital to interrogate the right ventricular (rv) lead and it was noted the rv lead exhibited high impedance.In addition, during the revision procedure, blood was observed between the silicone coating of the lead.The rv lead was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Manufacturer Narrative

Product event summary: the full lead was returned and analysis indicated the inner insulation of the lead was extrinsically breached due to a cut.It was noted the overlay tubing of the lead was extrinsically breached due to a cut at 23cm.The analyst commented the cut may have occurred during implant.It was also noted there was blood on a defibrillation conductor and it was not obstructed.The analyst commented there was a small amount of body fluid visible in the conductor and that the helix was slightly bent but still operated within specifications.Visual summary analysis of the lead indicated damage at implant.

• 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: 4678575
• MDR Text Key: 5637379
• Report Number: 2649622-2015-03594
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

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: 06/24/2016
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2014
• 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; Required Intervention
• Patient Age: 00071 YR