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

Model Number 429688

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Syncope (1610)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-45 lead, implanted: (b)(6) 2019, ddbb1d1 icd, implanted: (b)(6) 2019, 6937a-65 lead, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was experiencing sycopal episodes.It was noted the patient had leads implanted in the coronary sinus and the left ventricle and was programmed to right ventricular sensing.There was oversensing of the p-waves that resulted in inhibited right ventricular pacing.Reprogramming to true bipolar sensing was performed and the outcome was resolved.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY PLUS 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: 9537951
• MDR Text Key: 173289467
• Report Number: 2649622-2020-00049
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169860131
• UDI-Public: 00643169860131
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2021
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 01/02/2020
• Date Device Manufactured: 02/27/2019
• 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: 310C33 VALVE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 76