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

Model Number 419688

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 6996sq41 lead, implanted (b)(6) 2011; dtma1d1 crtd, implanted (b)(6) 2020; heartmate 3 lvad.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that interrogation showed a noisy left ventricular electrogram signal that the caller noted was also present at previous device checks.The left ventricular (lv) lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY 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: 11194743
• MDR Text Key: 227576135
• Report Number: 2649622-2021-01190
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00613994469731
• UDI-Public: 00613994469731
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2011
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2021
• Date Device Manufactured: 11/01/2010
• 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: 694765 LEAD, 407645 LEAD
• Patient Age: 76 YR
• Patient Weight: 76