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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV

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GUIDANT PUERTO RICO BV Back to Search Results
Model Number BRADY LEAD
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2015
Event Type  malfunction  
Event Description
Boston scientific received information that this implantable lead dislodged.The physician is considering repositioning it.No adverse patient effects were reported.Attempts to obtain additional information were unsuccessful.All available information indicates that the lead remains in service.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
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Manufacturer (Section D)
GUIDANT PUERTO RICO BV
Manufacturer (Section G)
GUIDANT PUERTO RICO BV
Manufacturer Contact
sonali vasekar
4100 hamline ave. n
st. paul, MN 55112
6515824786
MDR Report Key4883123
MDR Text Key5863806
Report Number2124215-2015-07094
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 05/01/2015
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 Model NumberBRADY LEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 05/01/2015
Initial Date FDA Received07/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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