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

Model Number 419378

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

Patient Problems Undesired Nerve Stimulation (1980); Occlusion (1984)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: c4tr01 crt-p, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right ventricular (rv) lead exhibited chronic high pacing thresholds.The lead was explanted and replaced.The left ventricular (lv) lead was causing chronic phrenic nerve stimulation for the patient.The lead was turned off and was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

The ra lead was then replaced.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

The right atrial (ra) lead required removal to gain access through the superior vena cava (svc).No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN OTW
• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8429060
• MDR Text Key: 139086055
• Report Number: 2649622-2019-04497
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00885074200729
• UDI-Public: 00885074200729
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/21/2010
• Device Model Number: 419378
• Device Catalogue Number: 419378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2019
• Date Device Manufactured: 02/12/2008
• 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: 407652 LEAD, 407658 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR