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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 Problem Operating System Becomes Nonfunctional (2996)
Patient Problems Edema (1820); Patient Problem/Medical Problem (2688)
Event Date 03/14/2017
Event Type  Injury  
Event Description
A report was received that the patient had been revised previously and the device was still not working. It was noted that the patient was experiencing lymphedema and neuropathy. The patient underwent an explant procedure.
 
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Type of DeviceSPINAL 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 Key6453089
MDR Text Key71489287
Report Number3006630150-2017-01114
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Patient
Type of Report Initial
Report Date 03/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
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 Treatment Data
Date Received: 04/03/2017 Patient Sequence Number: 1
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