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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-9218-15
Device Problem Device Stops Intermittently (1599)
Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330)
Event Date 03/06/2018
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-9218-15, serial#: (b)(4), description: precision m8 adapter, 15cm. Model#: sc-1132. Serial#: (b)(4), description: precision spectra implantable pulse generator the explanted devices were not returned to bsn.

 
Event Description

A report was received that the patient was experiencing discomfort. It was noted that the stimulation was shutting on and off periodically even after the reprogramming. The patient underwent a revision procedure wherein the m8 adapters and ipg were replaced. The patient was doing well.

 
Manufacturer Narrative

Additional information was received that the explanted device was inconsistent in delivering therapy. The physician believed that the coverage/pain relief would be better by replacing the entire system.

 
Event Description

A report was received that the patient was experiencing discomfort. It was noted that the stimulation was shutting on and off periodically even after the reprogramming. The patient underwent a revision procedure wherein the m8 adapters and ipg were replaced. The patient was doing well.

 
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Brand NamePRECISION SPECTRA
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 Key7456207
MDR Text Key106354221
Report Number3006630150-2018-01449
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN Number030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/20/2019
Device MODEL NumberSC-9218-15
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/23/2017
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: 04/24/2018 Patient Sequence Number: 1
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