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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-2352-70
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)
Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2017
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model: sc-2352-70 serial: (b)(4), description: linear 3-4 lead, 70cm.
 
Event Description
A report was received that the patient underwent a lead revision procedure due to lead migration of both leads.During the revision, the physician noticed that one of the leads had a rough edge over the end electrodes.Upon closer examination, it appeared that some of the wires were protruding.The lead was replaced and both leads were repositioned.The patient was stable post-operatively.
 
Manufacturer Narrative
Additional information was received that the patient experienced inadequate therapy due to lead migration.Analysis of the explanted lead sc-2352-70 (b)(4) revealed that the complaint has been confirmed.Visual inspection of the lead found that the lead proximal end is fractured between contacts 3 and 4.There are no exposed cables at the fractured portion of the proximal end.The cause of the proximal array damage could not be determined.
 
Event Description
A report was received that the patient underwent a lead revision procedure due to lead migration of both leads.During the revision, the physician noticed that one of the leads had a rough edge over the end electrodes.Upon closer examination, it appeared that some of the wires were protruding.The lead was replaced and both leads were repositioned.The patient was stable post-operatively.
 
Event Description
A report was received that the patient underwent a lead revision procedure due to lead migration of both leads.During the revision, the physician noticed that one of the leads had a rough edge over the end electrodes.Upon closer examination, it appeared that some of the wires were protruding.The lead was replaced and both leads were repositioned.The patient was stable post-operatively.
 
Event Description
A report was received that the patient underwent a lead revision procedure due to lead migration of both leads.During the revision, the physician noticed that one of the leads had a rough edge over the end electrodes.Upon closer examination, it appeared that some of the wires were protruding.The lead was replaced and both leads were repositioned.The patient was stable post-operatively.
 
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Brand Name
PRECISION SPECTRA
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 Key7050696
MDR Text Key92713496
Report Number3006630150-2017-04885
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729789581
UDI-Public08714729789581
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/08/2018
Device Model NumberSC-2352-70
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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