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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 419678
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/17/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.No anomalies were found.Visual analysis of the lead indicated apparent explant damage.Concomitant medical products: product id: 5076-52 lead, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient's system was removed due to infection.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 Key8638856
Report Number2649622-2019-08904
Device Sequence Number2286274
Product Code OJX
UDI-Device Identifier00643169860025
UDI-Public00643169860025
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P080006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/23/2019
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 Date07/12/2019
Device Model Number419678
Device Catalogue Number419678
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/30/2019
Initial Report FDA Received Date05/23/2019
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
DTMA1D4 ICD, 6935M62, LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age73 YR
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