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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

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MPRI ATTAIN PERFORMA; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 459888
Device Problem Positioning Problem (3009)
Patient Problem Perforation of Vessels (2135)
Event Date 03/19/2015
Event Type  Injury  
Event Description
It was reported that the left ventricular (lv) lead was attempted but not used during the implant procedure.The lead kept backsliding during placement and caused vessel perforation.The lead was removed and replaced with a new model.The replacement lead also was difficult to place and would not remain positioned during placement.The lead was removed and replaced with another model.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
 
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Brand Name
ATTAIN PERFORMA
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)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key4831083
MDR Text Key15384264
Report Number2649622-2015-05722
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P080006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/19/2015
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
Device Operator Health Professional
Device Expiration Date12/19/2015
Device Model Number459888
Device Catalogue Number459888
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/19/2015
Initial Date FDA Received06/10/2015
Date Device Manufactured01/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
Patient Weight90
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