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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN ABILITY PLUS MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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MPRI ATTAIN ABILITY PLUS MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 429688
Medical Device Problem Code High Capture Threshold (3266)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/07/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 5092-58, 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 left ventricular (lv) lead exhibited high 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 PLUS 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 Key10906737
Report Number2649622-2020-22993
Device Sequence Number14224011
Product Code OJX
UDI-Device Identifier00643169601796
UDI-Public00643169601796
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P080006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
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) 11/25/2020
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 Date09/19/2018
Device Model Number429688
Device Catalogue Number429688
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/16/2020
Initial Report FDA Received Date11/25/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age79 YR
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