MAUDE Adverse Event Report: MPRI ATTAIN ABILITY STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 439688

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

Patient Problems Death (1802); Fever (1858); Unspecified Infection (1930); Sepsis (2067); Weakness (2145)

Event Date 06/18/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: dtma1d1 crtd, implanted: (b)(6) 2018; 305u225 tissue valve, implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient developed (b)(6) bacteremia and sepsis approximately nine months po st device replacement and passed away.The cause of death and source of the infection was requested and not received.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information reported the patient had initially presented to the emergency room with fever, generalized weakness and disorientation.The patients device system became infected due to bacteremia.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported the patient was treated with intravenous antibiotics via a peripherally inserted central catheter (picc) and discharged to a skilled nursing facility.The patient was readmitted to the hospital after the picc line had dislodged.It was re-inserted and antibiotics were continued.The device therapies were suspended at the request of the family and the patient was discharged to an inpatient hospice facility where the patient passed away.The patient is a participant in the post approval clinical surveillance product surveillance registry.

• Brand Name: ATTAIN ABILITY STRAIGHT MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• 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: 9413780
• MDR Text Key: 169159090
• Report Number: 2649622-2019-22657
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00613994719058
• UDI-Public: 00613994719058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• 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,Followup,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/08/2014
• Device Model Number: 439688
• Device Catalogue Number: 439688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Date Device Manufactured: 01/10/2013
• 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
• Treatment: 5076-52 LEAD, 694765 LEAD
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 81