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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION; SPINAL CORD STIMULATOR Back to Search Results
Device Problems Device Inoperable (1663); Appropriate Term/Code Not Available (3191)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
Date of event: 2016.Expiration date: ni.
 
Event Description
A report was received that the patients ipg was no longer functioning.The patient will undergo an explant procedure.
 
Manufacturer Narrative
Additional information was received that the patient was a non-bsc patient, confirmed by the physician.
 
Event Description
A report was received that the patients ipg was no longer functioning.The patient will undergo an explant procedure.
 
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Brand Name
NI
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 Key7645452
MDR Text Key112573320
Report Number3006630150-2018-02184
Device Sequence Number1
Product Code LGW
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 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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