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

Model Number 479888

Device Problems Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problem Fall (1848)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient fell.An x-ray and computerized tomography (ct) scan confirmed the left ventricular (lv) lead micro dislodged.Elevated thresholds on the lead were additionally noted.Reprogramming was conducted and a replacement procedure when device needs to be replaced is tentatively planned.The lead remains in use.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN STABILITY QUAD 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: 11028756
• MDR Text Key: 222077016
• Report Number: 2649622-2020-24821
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169860421
• UDI-Public: 00643169860421
• 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: 12/17/2020

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: 02/21/2022
• Device Model Number: 479888
• Device Catalogue Number: 479888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/17/2020
• Date Device Manufactured: 03/12/2020
• 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: W4TR03 CRTP, 5076-52 LEAD, 5076-58 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 99