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

Model Number	439678
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a device upgrade procedure the existing right atrial (ra) and left ventricular (lv) leads had to also be explanted and replaced due to adhesion between the leads.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned in segments, analyzed.Analysis indicated the outer insulation was ruptured.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The right ventricular (rv) lead that was electively explanted and replaced was returned and analyzed.The rv lead tested out of specification for the outer insulation being ruptured.

• Brand Name: ATTAIN ABILITY STRAIGHT MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 11495919
• Report Number: 2649622-2021-05099
• Device Sequence Number: 19826354
• Product Code: OJX
• UDI-Device Identifier: 00613994719096
• UDI-Public: 00613994719096
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/07/2012
• Device Model Number: 439678
• Device Catalogue Number: 439678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: W1TR03 CRTP, 5076-52 LEAD, 5076-45 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR