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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-2218-50
Device Problems Bent (1059); Fracture (1260); Kinked (1339); Migration or Expulsion of Device (1395); Component Missing (2306)
Patient Problem Pain (1994)
Event Date 12/08/2017
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator.

 
Event Description

A report was received that the ipg was pushing against the patients spine and was painful. The patient underwent a revision procedure wherein the ipg was relocated and then one of the patients lead was replaced due to lead fracture. Device malfunction was suspected of the explanted lead. The patient was doing well post operatively.

 
Manufacturer Narrative

Additional information was received that the physician removed the silicone material from the patients body during the revision procedure.

 
Event Description

A report was received that the ipg was pushing against the patients spine and was painful. The patient underwent a revision procedure wherein the ipg was relocated and then one of the patients lead was replaced due to lead fracture. Device malfunction was suspected of the explanted lead. The patient was doing well post operatively.

 
Manufacturer Narrative

A review of the manufacturing documentation for the products revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing.

 
Event Description

A report was received that the ipg was pushing against the patients spine and was painful. The patient underwent a revision procedure wherein the ipg was relocated and then one of the patients lead was replaced due to lead fracture. Device malfunction was suspected of the explanted lead. The patient was doing well post operatively.

 
Manufacturer Narrative

Sc-2218-50 (b)(4) device evaluation indicated that the lead complaint has been confirmed. Visual inspection found that the lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark. The fracture location is 24 cm from the distal end. X-ray inspection confirmed 6 cables were fractured (electrodes 1, 2, 4-7). There are no exposed cables at the clik site fracture. Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event. Sc-4316 (ln 17801468) device evaluation indicated that the clik anchor has torn eyelet with missing silicone material.

 
Event Description

A report was received that the ipg was pushing against the patients spine and was painful. The patient underwent a revision procedure wherein the ipg was relocated and then one of the patients lead was replaced due to lead fracture. Device malfunction was suspected of the explanted lead. The patient was doing well post operatively.

 
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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 Key7155482
MDR Text Key96071547
Report Number3006630150-2017-05543
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,Followup
Report Date 02/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/25/2017
Device MODEL NumberSC-2218-50
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/17/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2015
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: 12/29/2017 Patient Sequence Number: 1
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