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

Model Number 429878

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.The analysis indicated that the distal conductor of the lead was obstructed due to a stylet/guidewire fragment stuck in the lumen.The stylet/guidewire was broken.The stylet/guidewire was kinked/buckled.Visual analysis of the lead indicated damage at implant.The analyst noted the full lead was returned with a fragment of the guidewire stuck in the lead.The guidewire is broken.The distal tip of the guidewire is kink/buckled in the distal tip nose of the lead.Guidewire test could not be performed as a fragment of the guidewire is stuck in the lumen of the lead.Guidewire is of unknown manufacturer.If information is provided in the future, a supplemental report will be issued.

Event Description

The left ventricular (lv) lead was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA 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: 10818369
• MDR Text Key: 215582465
• Report Number: 2649622-2020-21862
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601826
• UDI-Public: 00643169601826
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/26/2021
• Device Model Number: 429878
• Device Catalogue Number: 429878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2019
• 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
• Patient Age: 73 YR