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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN ABILITY STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
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MPRI ATTAIN ABILITY STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P Back to Search Results
Model Number 439678
Medical Device Problem Code Capturing Problem (2891)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/23/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant products: dtba1d4 crt-d implanted (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the left ventricular (lv) lead exhibited a gradual increase in pacing thresholds.The lead remains in use. no patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN ABILITY STRAIGHT MRI SURESCAN
Common Device Name
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key12431804
Report Number2649622-2021-18128
Device Sequence Number11657209
Product Code OJX
UDI-Device Identifier00613994719096
UDI-Public00613994719096
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 Year2014
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date06/13/2016
Device Model Number439678
Device Catalogue Number439678
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/01/2021
Initial Report FDA Received Date09/07/2021
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
5076-52 LEAD, 6947M62 LEAD
Patient Age66 YR
Patient Weight72
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