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

Model Number 6947M62

Device Problems Device Contamination with Body Fluid (2317); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 10/14/2014

Event Type  Injury  

Event Description

It was reported that within a week of implant, the right ventricular (rv) lead was found to have dislodged.The lead was attempted to be repositioned, but during the procedure, blood was found in the lead lumen, which in turn was leaking into the device header.The lead and device were explanted and replaced.No patient complications have been 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.Product event summary: the full lead was returned and analyzed.Both the outer insulation and the inner tubing of the lead were extrinsically breached due to a cut, and blood was found on the distal conductor of the lead and it was obstructed.The distal lv (low voltage) electrode of the lead was covered in blood and body tissue/fibrotic growth, and visual summary analysis of the lead indicated apparent explant damage.(b)(4).

• 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: 4313333
• MDR Text Key: 5207549
• Report Number: 2649622-2014-14018
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2016
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2014
• 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
• Treatment: DVBB1D4 ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00054 YR
• Patient Weight: 116