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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1160
Device Problem Intermittent Energy Output (4025)
Patient Problems Headache (1880); Unspecified Infection (1930); Nausea (1970); Vomiting (2144); Fluid Discharge (2686)
Event Date 02/20/2020
Event Type  Injury  
Event Description
A report was received that the patient was having a lot of clear fluid near the ipg site.Positional headaches, nausea and vomiting were noted.It was also reported that the stimulation goes off and on when walking or making posture changes.Database analysis revealed no anomalies.
 
Event Description
A report was received that the patient was having a lot of clear fluid near the ipg site.Positional headaches, nausea and vomiting were noted.It was also reported that the stimulation goes off and on when walking or making posture changes.Database analysis revealed no anomalies.
 
Manufacturer Narrative
Additional information was received that the physician did not see a clear fluid near the ipg site.
 
Event Description
A report was received that the patient was having a lot of clear fluid near the ipg site.Positional headaches, nausea and vomiting were noted.It was also reported that the stimulation goes off and on when walking or making posture changes.Database analysis revealed no anomalies.
 
Manufacturer Narrative
Additional information was received that the patient is in need of surgery due to infection concerns.It was mentioned that patient googled the symptoms of headache and feeling ill and daignosed himself having a cerebrospinal fluid (csf) leak.The physician never confirmed csf leak or other infection.
 
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Brand Name
SPECTRA WAVEWRITER
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key9838912
MDR Text Key183695466
Report Number3006630150-2020-01222
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729951254
UDI-Public08714729951254
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 05/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/27/2021
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number363727
Was Device Available for Evaluation? No
Date Manufacturer Received04/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age32 YR
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