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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1110-02
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2018
Event Type  malfunction  
Manufacturer Narrative
Sc-1110-02 (sn (b)(4)) device evaluation indicated that the device passed all tests performed.
 
Event Description
A report was received that the patient could not feel any stimulation.It was noted that ipg was non-functional.The patient underwent an ipg replacement procedure and was doing well postoperatively.The physician suspected device malfunction.
 
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Brand Name
PRECISION
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 Key7623645
MDR Text Key111843573
Report Number3006630150-2018-02181
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767688
UDI-Public08714729767688
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
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/01/2014
Device Model NumberSC-1110-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/30/2018
Initial Date FDA Received06/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2012
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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