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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-2316-70
Device Problems Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2017
Event Type  malfunction  
Manufacturer Narrative
Additional suspect medical device component (s) involved in the event: model # sc-2316-70 serial # (b)(4) description: infinion 70 cm lead kit.
 
Event Description
A report was received that the patient loss stimulation.During reprogramming it was noticed that the two implanted leads exhibited high impedances.Lead breakage is suspected, however breakage was not confirmed per the x-ray results.
 
Manufacturer Narrative
Additional information was received that the patient underwent a lead replacement procedure.Per the physician assessment the leads were broken, however there were no exposed cables.The patient is doing well post-operatively.
 
Event Description
A report was received that the patient loss stimulation.During reprogramming it was noticed that the two implanted leads exhibited high impedances.Lead breakage is suspected, however breakage was not confirmed per the x-ray results.
 
Manufacturer Narrative
Sc-2316-70 sn (b)(4): device analysis of the lead revealed that the complaint of high impedances was confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 20 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 10 cm from tip of proximal end.The fractured cables resulted in the reported high impedances.Sc-2316-70 sn (b)(4): device analysis of the lead revealed that the complaint of high impedances was confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 22 cm from the distal end.Cables were not exposed at the clik anchor fracture site.X-ray inspection confirmed 12 cables were fractured (electrodes 1-7, 10-14) at the bent/kinked section of the lead.The fractured cables resulted in the reported high impedances.
 
Event Description
A report was received that the patient loss stimulation.During reprogramming it was noticed that the two implanted leads exhibited high impedances.Lead breakage is suspected, however breakage was not confirmed per the x-ray results.
 
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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 Key7169887
MDR Text Key96576821
Report Number3006630150-2018-00053
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797821
UDI-Public08714729797821
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
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/09/2018
Device Model NumberSC-2316-70
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2016
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) Required Intervention;
Patient Age55 YR
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