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

Model Number 6947M62

Device Problems Break (1069); Device Contamination with Body Fluid (2317); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient's right ventricular (rv) lead had high and unstable thresholds and impedance.Additionally, the lead had a possible fracture and a possible connection issue.The lead was capped and replaced.The device remains in use.During the replacement of the lead, the new lead was difficult to place in the patient due to their anatomy.Blood appeared inside the insulation of the lead body and there was a possible insulation break.The lead was not used and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.Analysis indicated that the outer insulation of the lead was extrinsically breached due to a cut.The overlay tubing of the lead was extrinsically breached due to a cut.The outer insulation of the lead was observed to have blood ingression.The overlay tubing of the lead was observed to have blood ingression.Visual summary analysis of the lead indicated damage at implant.

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): 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: 5557155
• MDR Text Key: 42776888
• Report Number: 2649622-2016-03345
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• 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: 00054 YR