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

Model Number 429888

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

Patient Problems Death (1802); High Blood Pressure/ Hypertension (1908); Sepsis (2067); Septic Shock (2068); Pericardial Effusion (3271)

Event Date 08/27/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 6935m62 lead 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 was admitted for hypotension, depressive disorder and possible sepsis with shock norepinephrine.It was noted that the patient had chronic renal failure and received hemodialysis.Due to the multisystem failure and the patient showing little improvement after receiving aggressive care, the patient chose to enter hospice care.The patient was exhibited decompensation due to severe pulmonary hypertension, a dilated inferior vena cava, and an increased pericardial effusion.It was noted that the sepsis source was unclear, but treatment for strept infantarius bacteremia was delivered.After being admitted to hospice care, the patient exhibited ascites and cirrhosis and received palliative frequent paracentesis.The patient passed away a few days after admittance to hospice.The patient is a participant in the (b)(6) clinical study.

• Brand Name: ATTAIN PERFORMA 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: 9643775
• MDR Text Key: 176858120
• Report Number: 2649622-2020-02338
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601833
• UDI-Public: 00643169601833
• 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
• Report Date: 01/29/2020

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: 01/15/2020
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/29/2020
• Date Device Manufactured: 02/06/2018
• 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: 407645 LEAD, DTMA1QQ CRTD
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 83