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 MRI SURESCAN; 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 MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 4296
Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291)
Patient Problems Stenosis (2263); No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2019
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the left ventricular pacing lead was beyond the expected upper range.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there was an increased and high impedance on the superior vena cava (svc) and right ventricular (rv) defibrillation coils of the rv lead.There was also no capture and high undefined impedance on the left ventricular (lv) lead.Both rv and lv leads were suspected of fracture.The leads remain in use.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the left ventricular pacing lead was beyond the expected upper range.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported the doctor have attempt to re-insert a new lead unfortunately there was vein stenosis.No further 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 MRI SURESCAN
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8897528
MDR Text Key154442602
Report Number2649622-2019-14412
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
P080006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/03/2012
Device Model Number4296
Device Catalogue Number4296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
694765 LEAD
Patient Outcome(s) Hospitalization; Required Intervention;
-
-