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

Model Number 6947M62

Device Problems Signal Artifact/Noise (1036); Collapse (1099); Over-Sensing (1438); Low impedance (2285); Impedance Problem (2950); Torn Material (3024)

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

Event Date 07/28/2017

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead had an alert for low rv tip to rv coil impedance.It was noted the lead was programmed bipolar.The lead remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing associated with the right ventricular lead.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was below the expected lower range.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported the right ventricular (rv) lead integrity alert (lia) had triggered for high rate non-sustained episodes and a high sensing integrity counter (sic).It was noted the rv bipolar and rv tip/rv coil impedances has dropped significantly and were low.Lead noise was observed on the high rate non-sustained episodes.During the lead removal it was noted the lead insulation had damage and was torn and crushed in the area where the lead went threw the clavicle and rib.The lead was explanted 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 inner insulation of the lead developed a breach at the first rib/clavicle location while in vivo.The outer insulation of the lead was breached due to bi/multi-lumen tubing voids while in vivo.The outer insulation of the lead developed a breach at the first rib/clavicle location while in vivo.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: 6921017
• MDR Text Key: 89511656
• Report Number: 2649622-2017-10890
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00643169309722
• UDI-Public: 00643169309722
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/15/2017
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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: 60 YR