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

Model Number 439888

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Migration (4003)

Patient Problems Erosion (1750); No Code Available (3191)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 6935m55 lead, implanted (b)(6) 2017; dtba1qq device, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the implanted leads migrated and/or clustered in the device pocket with a lead segment beginning to protrude under the skin.The cardiac resynchronization therapy defibrillator (crt-d) system was extracted and a temporary pacing lead was implanted until a system replacement could be performed.The system was later 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.

Manufacturer Narrative

Product event summary: the proximal portion of the lead was returned, analyzed, and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN PERFORMA STRAIGHT 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
• MDR Report Key: 7760720
• MDR Text Key: 116358577
• Report Number: 2649622-2018-12928
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601857
• UDI-Public: 00643169601857
• Combination Product (y/n): N
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2018
• Device Model Number: 439888
• Device Catalogue Number: 439888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 04/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5554-53 LEAD; 5554-53 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR