MAUDE Adverse Event Report: MPRI ATTAIN BIPOLAR OVER THE WIRE LEAD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 419478

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

Patient Problems Unspecified Infection (1930); Necrosis (1971)

Event Date 12/24/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 5076-52 lead, implanted: (b)(6) 2007.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was skin necrosis on the device site.An infection was strongly suspected based on the appearance.The device remains in use.No further patient complications have been reported as a result of this event.It was further reported that the cardiac resynchronization therapy defibrillator (crt-d) system was explanted due to the skin necrosis and suspected infection.

• Brand Name: ATTAIN BIPOLAR OVER THE WIRE LEAD
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13337853
• MDR Text Key: 284357782
• Report Number: 2649622-2022-01648
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/07/2009
• Device Model Number: 419478
• Device Catalogue Number: 419478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2022
• Date Device Manufactured: 04/02/2007
• 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: DTBA2D4 CRTD, 6935M72 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male