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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 439678
Device Problems Failure to Capture (1081); High impedance (1291); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/21/2014
Event Type  malfunction  
Event Description
It was reported that during an implant procedure, the left ventricular lead had "some concern of lead function" in that there was higher impedance, no threshold, and tactile concern.The lead was not implanted and another lead was used.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary : the full lead was returned and analyzed with no anomalies found.The proximal and distal conductors were kinked/buckled.There were breached and cosmetic cuts on the outer insulation and blood ingression was observed on the outer insulation.Visual analysis noted the lead was damaged at implant.(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 DISEASE MGMT
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
nashoane fulwood-kelley
8200 coral sea st ne
mounds view, MN 55112
7635260583
MDR Report Key3859124
MDR Text Key20014662
Report Number2649622-2014-06106
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 03/21/2014
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 Health Professional
Device Expiration Date04/30/2015
Device Model Number439678
Device Catalogue Number439678
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2014
Initial Date FDA Received06/10/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age00079 YR
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