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

Model Number 419478

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Fever (1858); Unspecified Infection (1930); Necrosis (1971)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 419478 lead; 5866-38m lead, implanted: (b)(6) 2009.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient developed an infection caused by the erosion of the cardiac resynchronization therapy defibrillator (crt-d).It was noted that the patient developed a fever.It was also noted that skin necrosis and wound dehiscence was observed.Blood cultures were taken, but the results were not yet obtained.Antibiotics were administered and prescribed for one month.The crt-d system was removed.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: 8166342
• MDR Text Key: 130408497
• Report Number: 2649622-2018-20699
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2011
• Device Model Number: 419478
• Device Catalogue Number: 419478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• Date Device Manufactured: 08/06/2009
• 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: 5554-53 LEAD, 6944-58 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR