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

Model Number 419478

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

Patient Problems Unspecified Infection (1930); Septic Shock (2068)

Event Date 10/23/2020

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: dtmb1d1 crt-d, implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the by patient's family member that the patient is deceased and died approximately two and a half weeks post device changeout.The patient is reported to have had an infection and septic shock.It was further reported that the device ¿didn't work¿during a ¿code¿.Additional information was requested and not received.

• 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: 10906472
• MDR Text Key: 218483628
• Report Number: 2649622-2020-22986
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00885074113364
• UDI-Public: 00885074113364
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/29/2011
• Device Model Number: 419478
• Device Catalogue Number: 419478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Date Device Manufactured: 06/12/2009
• 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
• Patient Outcome(s): Death
• Patient Age: 67 YR