MAUDE Adverse Event Report: MPRI ATTAIN CS; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 2188-75

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cardiomyopathy (1764); Liver Damage/Dysfunction (1954); Tricuspid Regurgitation (2112); Ascites (2596)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 8042b crtp, implanted: (b)(6) 2007; fr995-27 tissue valve, implanted: (b)(6) 2002; mcs-p3-29-aoa-us transcatheter valve, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced tricuspid regurgitation and non-ischemic cardiomyopathy leading to liver dysfunction and ascites requiring multiple paracenteses.It was further reported that there was severe pulmonary right ventricle, right atrial and increased right atrial pressure.During the procedure to replace the tricuspid valve, the right ventricular (rv) lead and the left ventricular (lv) lead were found to be crossing the tricuspid annulus.The left ventricular (lv) lead was also noted to not be in the left ventricle, but was in the right ventricle through the tricuspid valve.Both the rv and the lv leads were explanted and replaced.The tricuspid valve was also replaced.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN CS
• 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: 9612268
• MDR Text Key: 175732103
• Report Number: 2649622-2020-01615
• Device Sequence Number: 1
• Product Code: LWP
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2003
• Device Model Number: 2188-75
• Device Catalogue Number: 2188-75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2020
• 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: 4058M52 LEAD, 5024M-58 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR