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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-2316-50
Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2018
Event Type  malfunction  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model: sc-2316-50, serial: (b)(4), description: infinion 1x16 perc lead kit-50 cm; model: sc-3400-30, serial: (b)(4) and 667493 description: infinion splitter 2x8 kit (30 cm).
 
Event Description
A report was received that high impedances were observed on the patients two leads.Per the physician assessment, the cause of the high impedances was a separation at the connection sites of the lead and lead splitters.The physician indicated that the cause of the separation was tension applied at the upper part of the lead splitter during an unrelated procedure.The patient underwent a revision procedure wherein the two leads and two lead splitters were replaced.The patient is doing well post-operatively.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: model: sc-4316 lot: 19292862 description: next generation anchor kit-sterile sc-3400-30 sn (b)(4) the returned splitters were analyzed and no anomalies were found.Sc-2316-50 sn (b)(4) device analysis of lead revealed that the lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 23 cm from the distal end.Cables were not exposed at the clik anchor fracture site.X-ray inspection confirmed that cables were fractured at the bent/kinked section of the lead.Additionally, the lead was cleanly cut at 23 cm from tip of distal end.The fractured cables resulted in the reported high impedances.Sc-2316-50 sn (b)(4) device analysis of lead revealed that the lead was cleanly cut at 26 cm from tip of distal end.Damage to the device is similar to that of the typical explant damage and was not considered a failure.X-ray inspections found no cable breakage.Sc-4316: the clik anchor has a torn eyelet with missing silicone material.Additional information was received confirming that no silicone material was left in the patient body.
 
Event Description
A report was received that high impedances were observed on the patients two leads.Per the physician assessment, the cause of the high impedances was a separation at the connection sites of the lead and lead splitters.The physician indicated that the cause of the separation was tension applied at the upper part of the lead splitter during an unrelated procedure.The patient underwent a revision procedure wherein the two leads and two lead splitters were replaced.The patient is doing well 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 Key7294156
MDR Text Key100932257
Report Number3006630150-2018-00816
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797814
UDI-Public08714729797814
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/28/2019
Device Model NumberSC-2316-50
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2017
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 Age72 YR
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