MAUDE Adverse Event Report: MPRI ATTAIN OTW; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 419488

Device Problem Degraded (1153)

Patient Problem Unspecified Infection (1930)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.Analysis indicated that the outer insulation was ruptured.The outer insulation of the lead was distorted due to kinking/buckling.The analyst noted that visual inspection found the outer insulation breached in vivo/ ruptured.It was happened at a kink location.Concomitant: 6947m62 lead, implanted: (b)(6) 2015; 5076-52 lead, implanted: (b)(6) 2014.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) system was explanted due to an infection.A temporary pacing lead was placed until the infection clears.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN OTW
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• 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: 7255180
• MDR Text Key: 99581124
• Report Number: 2649622-2018-01039
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00885074113371
• UDI-Public: 00885074113371
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• 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
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2015
• Device Model Number: 419488
• Device Catalogue Number: 419488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• 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; Required Intervention
• Patient Age: 53 YR