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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-8120-70
Device Problems Break (1069); High impedance (1291)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2017
Event Type  Malfunction  
Event Description

A report was received that during the patient's recent surgery (mfr report #: 3006630150-2017-04749), the lead was discovered to be damaged at the proximal end. It was also noted that there were high impedances on two contacts. The physician cut the proximal end of the lead and left the remaining lead in the body. The patient will undergo a revision procedure wherein the lead will be replaced.

 
Manufacturer Narrative

Additional information was received that no further course of action will be taken at this time.

 
Event Description

A report was received that during the patients recent surgery (mfr report #: 3006630150-2017-04749), the lead was discovered to be damaged at the proximal end. It was also noted that there were high impedances on two contacts. The physician cut the proximal end of the lead and left the remaining lead in the body. The patient will undergo a revision procedure wherein the lead will be replaced.

 
Manufacturer Narrative

Additional information was received that the patient underwent a lead replacement procedure. No device malfunction was suspected. The patient was doing well postoperatively. The explanted device was not returned to bsn. A review of the manufacturing documentation for the lead revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

 
Event Description

A report was received that during the patients recent surgery (mfr report #: 3006630150-2017-04749), the lead was discovered to be damaged at the proximal end. It was also noted that there were high impedances on two contacts. The physician cut the proximal end of the lead and left the remaining lead in the body. The patient will undergo a revision procedure wherein the lead will be replaced.

 
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Brand NamePRECISION
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 Key7155230
MDR Text Key96066266
Report Number3006630150-2017-05516
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,Followup
Report Date 05/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2009
Device MODEL NumberSC-8120-70
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 Received04/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/31/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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