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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION
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BOSTON SCIENTIFIC NEUROMODULATION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Pneumonia (2011); Complaint, Ill-Defined (2331); No Code Available (3191)
Event Date 12/02/2018
Event Type  Injury  
Manufacturer Narrative
Date of birth: (b)(6).
 
Event Description
A report was received that the clinical patient was admitted due to pneumonia with fast atrial fibrillation and possible diastolic heart failure which was severe.The event was assessed as unlikely related to the procedure or the device.
 
Manufacturer Narrative
Additional information was received that the event was not related to the procedure or to the device.
 
Event Description
A report was received that the clinical patient was admitted due to pneumonia with fast atrial fibrillation and possible diastolic heart failure which was severe.The event was assessed as unlikely related to the procedure or the device.
 
Event Description
A report was received that the clinical patient was admitted due to pneumonia with fast atrial fibrillation and possible diastolic heart failure which was severe.The event was assessed as unlikely related to the procedure or the device.
 
Manufacturer Narrative
Additional information was received that the patient was treated with medication and discharged.
 
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Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key8312570
MDR Text Key135232490
Report Number3006630150-2019-00407
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received02/06/2019
Supplement Dates Manufacturer Received03/04/2019
04/19/2019
Supplement Dates FDA Received03/12/2019
05/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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