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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fever (1858); Nausea (1970); Pain (1994); No Code Available (3191)
Event Date 09/18/2020
Event Type  Injury  
Event Description
It was reported that the patient had prolonged hospitalization due to pain at the incision site.Physician assessed this was probably related to the procedure and not related to device hardware or stimulation.Additional information regarding the patient status to date has not been obtained despite good faith efforts.
 
Event Description
It was reported that the patient had prolonged hospitalization due to pain at the incision site.Physician assessed this was probably related to the procedure and not related to device hardware or stimulation.Additional information received that infection has been ruled out, and the event has been reported as resolved.
 
Manufacturer Narrative
H6 patient code 3191: no code available was used because there is not an equivalent fda code for additional intervention required.
 
Event Description
It was reported that the patient had prolonged hospitalization due to pain at the incision site.Physician assessed this was probably related to the procedure and not related to device hardware or stimulation.Additional information was received that infection has been ruled out, and the event has been reported as resolved.Additional information was received that the patient was admitted to the hospital with nausea, fever and pain at the incision sites.The physician assessed that the patient did not appear septic.A superficial skin swab grew klebsiella; however, an aspirate did not grow any bacteria.Two weeks of antibiotics were prescribed to treat the superficial wound infection.The patient was discharged from the hospital and the event had resolved.
 
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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 Key10683980
MDR Text Key211482609
Report Number3006630150-2020-04886
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 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/14/2021
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number362842
Was Device Available for Evaluation? No
Date Manufacturer Received03/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age63 YR
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