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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC B.V. ATTAIN STABILITY; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

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MEDTRONIC B.V. ATTAIN STABILITY; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 20066
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2014
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant procedure, the left ventricular (lv) lead had no acceptable electrical parameters.The lead was ultimately placed in the target area and remain in use.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN STABILITY
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Manufacturer (Section D)
MEDTRONIC B.V.
earl bakkenstraat 10
heerlen 6422 PJ
NL  6422 PJ
Manufacturer (Section G)
MEDTRONIC B.V.
earl bakkenstraat 10
heerlen 6422 PJ
NL   6422 PJ
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key8140808
MDR Text Key129575725
Report Number3002807561-2018-00041
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeIT
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
Report Date 12/07/2018
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
Device Operator Lay User/Patient
Device Expiration Date09/08/2016
Device Model Number20066
Device Catalogue Number20066
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2018
Initial Date FDA Received12/07/2018
Date Device Manufactured09/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DTBA2D1 ICD, 6947 LEAD, 20066 LEAD
Patient Age66 YR
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