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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1132
Device Problem Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2017
Event Type  malfunction  
Event Description
A report was received that the patients ipg turns on and off randomly thus the physician suspected device malfunction.The patient underwent an ipg replacement procedure and was doing well postoperatively.
 
Manufacturer Narrative
Sc-1132 (sn: (b)(4)) device evaluation indicated that the device passed all tests performed.
 
Event Description
A report was received that the patients ipg turns on and off randomly thus the physician suspected device malfunction.The patient underwent an ipg replacement procedure and was doing well postoperatively.
 
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Brand Name
PRECISION SPECTRA
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 Key6966017
MDR Text Key90660393
Report Number3006630150-2017-04324
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public08714729821526
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 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/06/2016
Device Model NumberSC-1132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2014
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 Age44 YR
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