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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-3400-30
Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Cut In Material (2454)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/17/2017
Event Type  malfunction  
Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-2316-50 serial #: (b)(4) description: infinion 1x16 perc lead kit50cm model#: sc-3400-30 serial #: (b)(4) description:infinion splitter 2x8 kit30 cm model#: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator model#: sc-4316 lot #: 16240019 description: next generation anchor kit-sterile the explanted clik anchor was not returned to bsn as it was discarded by the medical facility.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
 
Event Description
A report was received that the patient was experiencing inadequate stimulation due to high impedances.The physician suspected that the splitters were corrupted.The patient underwent a revision procedure wherein the ipg, leads, and clik anchor were replaced.During the explant, the leads and splitters were cut around the scar tissue.The patient was doing well postoperatively.
 
Manufacturer Narrative
Sc-2316-50 (b)(4) device evaluation indicated that the complaint has been confirmed.Visual inspection found that lead was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 19 cm from the tip of distal end.X-ray inspection confirmed 11cables were fractured (electrodes 1, 2, 4, 6-9, 13-16).There are no exposed cables at the clik site fracture.The fractured cables resulted in the reported high impedances.Sc-2316-50 (b)(4) device evaluation indicated that the complaint has been confirmed.Visual inspection found that lead was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 24 cm from the tip of distal end.X-ray inspection confirmed all cables were fractured.There are no exposed cables at the clik site fracture.The fractured cables resulted in the reported high impedances.Sc-3400-30 (b)(4) device evaluation indicated that the source of the complaint in regard to the high impedances was verified to be with the associated leads.Visual inspection revealed that the lead splitters were cleanly cut at 21 cm from proximal ends.X-ray inspections found no cable breakage.The clean cut damage is a result of a typical explant procedure and it is not considered a failure.Sc-1132 (b)(4) device evaluation indicated that the complaint in regard to the high impedances was verified to be with the associated leads.The ipg passed all the required tests and revealed normal device characteristics.Sc-4316 lot #: 16240019 it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
 
Event Description
A report was received that the patient was experiencing inadequate stimulation due to high impedances.The physician suspected that the splitters were corrupted.The patient underwent a revision procedure wherein the ipg, leads, and clik anchor were replaced.During the explant, the leads and splitters were cut around the scar tissue.The patient was doing well postoperatively.
 
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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 Key6772727
MDR Text Key82025329
Report Number3006630150-2017-02875
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797838
UDI-Public08714729797838
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/28/2014
Device Model NumberSC-3400-30
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2012
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 Age69 YR
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