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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN ABILITY MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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MPRI ATTAIN ABILITY MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 419688
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Muscle Stimulation (1412)
Date of Event 10/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: c6tr01 crt-p, implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient had experienced diaphragmatic stimulation from the left ventricular (lv) lead and that the lead was programmed off.No further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN ABILITY 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 Key9334405
Report Number2649622-2019-21289
Device Sequence Number13968983
Product Code OJX
UDI-Device Identifier00643169601772
UDI-Public00643169601772
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P080006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/18/2019
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 Date02/03/2018
Device Model Number419688
Device Catalogue Number419688
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/20/2019
Initial Report FDA Received Date11/18/2019
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
5076-45 LEAD, 5076-52 LEAD
Outcome Attributed to Adverse Event Required Intervention;
Patient Age82 YR
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