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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 Bacterial Infection (1735); Fever (1858); Unspecified Infection (1930); Itching Sensation (1943); Rash (2033); Impaired Healing (2378); No Code Available (3191)
Event Date 03/12/2019
Event Type  Injury  
Event Description
A report was received that the patient developed an infection.The patient underwent an explant procedure.
 
Manufacturer Narrative
Additional information was received that the location of the infection was in the lower back.Symptoms of fever, rash and itchiness were noted.The physician also confirmed that the infection was due to impaired wound healing.The patient was placed on antibiotics and was doing well.The explanted devices were not returned to bsn as they were discarded by the medical facility.
 
Event Description
A report was received that the patient developed an infection.The patient underwent an explant procedure.
 
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Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key8465568
MDR Text Key140361929
Report Number3006630150-2019-01414
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,health
Type of Report Initial,Followup
Report Date 04/18/2019
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? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/15/2019
Initial Date FDA Received03/29/2019
Supplement Dates Manufacturer Received04/01/2019
Supplement Dates FDA Received04/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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