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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 439878
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/25/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: 5076-52 lead, implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient's implantable cardioverter defibrillator (icd) system was explanted due to infection.No further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN PERFORMA 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 Key11286128
Report Number2649622-2021-02322
Device Sequence Number4607083
Product Code OJX
UDI-Device Identifier00643169002487
UDI-Public00643169002487
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P080006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/05/2021
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? No
Operator of Device Lay User/Patient
Device Expiration Date07/14/2017
Device Model Number439878
Device Catalogue Number439878
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/25/2021
Initial Report FDA Received Date02/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
6947M62 LEAD, DTBA1QQ CRT-D
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age67 YR
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