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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1160
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
Event Type  malfunction  
Manufacturer Narrative
The explanted device was not returned to bsn as it was discarded by the medical facility.A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing.
 
Event Description
A report was received that following a lead revision procedure, the patients ipg was not working.The patient underwent an ipg replacement procedure.It was suspected that the ipg might have been compromised during patients lead revision procedure.The patient was doing well postoperatively.
 
Manufacturer Narrative
Additional information was received that it was unknown if electrocautery was used during the patients lead revision procedure.Electrocautery is a known source of high voltage transient signal and current company labeling warns against the use of electrocautery.(physician¿s implant manual 90970880-04).
 
Event Description
A report was received that following a lead revision procedure, the patients ipg was not working.The patient underwent an ipg replacement procedure.It was suspected that the ipg might have been compromised during patients lead revision procedure.The patient was doing well postoperatively.
 
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Brand Name
SPECTRA WAVEWRITER
Type of Device
SPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key7588582
MDR Text Key110674113
Report Number3006630150-2018-02018
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729951254
UDI-Public08714729951254
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/03/2019
Device Model NumberSC-1160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
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