Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN ABILITY PLUS; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MPRI ATTAIN ABILITY PLUS; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 429678
Medical Device Problem Codes Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/06/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant products: 7742 lead, implanted (b)(6) 2016, 7741 lead, implanted (b)(6) 2016.
 
Event or Problem Description
It was reported that the left ventricular lead dislodged - as confirmed on a chest x-ray - and there was no capture, even at maximum output.A lead repositioning was attempted, however the target branch was not a stable location so the lead was explanted and replaced.No patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTAIN ABILITY PLUS
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 Key6783083
Report Number2649622-2017-09605
Device Sequence Number1539514
Product Code OJX
UDI-Device Identifier00643169601789
UDI-Public00643169601789
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P080006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/06/2017
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date01/10/2019
Device Model Number429678
Device Catalogue Number429678
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/06/2017
Initial Report FDA Received Date08/09/2017
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
C6TR01 IPG
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age76 YR
-
-