MAUDE Adverse Event Report: MPRI ATTAIN BIPOLAR OVER THE WIRE LEAD; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 419488

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

Patient Problems Dyspnea (1816); Fever (1858); Unspecified Infection (1930); Lethargy (2560)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 1258t lead, implanted: (b)(6) 2012.Dtmb1d1 crt-d, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient¿s spouse called to report that the patient¿s cardiac resynchronization therapy defibrillator (crt-d) system was explanted and replaced due to an infection or perhaps something wrong with the device.A follow up with the patient¿s healthcare provider yielded that the patient was admitted to the emergency room (er) with fever, lethargy, and shortness of breath.The patient was noted to have an infection with (b)(6).There were no product performance issue with the crt-d system.The crt-d system was removed due to the infection and a new system was implanted.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN BIPOLAR OVER THE WIRE LEAD
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9802800
• MDR Text Key: 182568240
• Report Number: 2649622-2020-04750
• 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: health professional,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/08/2013
• Device Model Number: 419488
• Device Catalogue Number: 419488
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/06/2020
• Date Device Manufactured: 08/18/2011
• 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: 84 YR