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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 429888
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.The analysis indicated that the distal conductor of the lead was obstructed due to a stylet/guidewire stuck in the lumen.The stylet/guidewire was damaged.The distal end/electrodes of the lead were extrinsically damaged.Visual analysis of the lead indicated damage at implant.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant attempt, the angioplasty guide got hooked with the lead.The wire and the lead were removed and a new wire and new lead were used.The lead subsequently tested out of specification during manufacturer¿s analysis.No patient complications have been reported as a result of this event.
 
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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)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7842700
MDR Text Key119082071
Report Number2649622-2018-14402
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeSP
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 09/04/2018
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 Health Professional
Device Expiration Date12/06/2019
Device Model Number429888
Device Catalogue Number429888
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/21/2018
Initial Date FDA Received09/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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