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U.S. Department of Health and Human Services

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

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MPRI ATTAIN ABILITY STRAIGHT; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 439688
Device Problem Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2014
Event Type  malfunction  
Event Description
It was reported that a left ventricular (lv) lead was attempted/not used due to the physician was unable to pass a competitors guidewire all the way through the lead.The lead was removed and a new lead was placed using the same guidewire.Once the second lead was placed the physician had difficulty removing the guidewire, which had apparently become stuck in the lead lumen.The physician was able to remove the guidewire and the lead remains in use.It was also noted that the physician had difficulty inserting a guidewire through the verogram balloon.The same guidewire was utilized with a new venogram balloon without incident.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.Analysis indicated the distal conductor was extrinsically distorted due to kinking/buckling.The proximal conductor of the lead became extrinsically distorted due to kinking/buckling, the information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
 
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Brand Name
ATTAIN ABILITY STRAIGHT
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 Key4496977
MDR Text Key5441170
Report Number2649622-2015-00547
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/03/2014
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 Physician
Device Expiration Date03/13/2015
Device Model Number439688
Device Catalogue Number439688
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2014
Initial Date FDA Received02/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2013
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
4641, COMPETITOR ACUITY WHISPER VIEW GUIDEWIRE
Patient Age00061 YR
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