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U.S. Department of Health and Human Services

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

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MPRI ATTAIN PERFORMA MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 429878
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2020
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 fragment stuck in the lumen.The stylet/guidewire was broken.The stylet/guidewire was kinked/buckled.Visual analysis of the lead indicated damage at implant.The analyst noted the full lead was returned with a fragment of the guidewire stuck in the lead.The guidewire is broken.The distal tip of the guidewire is kink/buckled in the distal tip nose of the lead.Guidewire test could not be performed as a fragment of the guidewire is stuck in the lumen of the lead.Guidewire is of unknown manufacturer.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The left ventricular (lv) lead was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN PERFORMA MRI SURESCAN
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10818369
MDR Text Key215582465
Report Number2649622-2020-21862
Device Sequence Number1
Product Code OJX
UDI-Device Identifier00643169601826
UDI-Public00643169601826
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/10/2020
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 Date09/26/2021
Device Model Number429878
Device Catalogue Number429878
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Initial Date Manufacturer Received 10/28/2020
Initial Date FDA Received11/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2019
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 Age73 YR
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