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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-8336-70
Device Problems Fracture (1260); Material Separation (1562); Device Or Device Fragments Location Unknown (2590)
Patient Problem Inadequate Pain Relief (2388)
Event Date 01/02/2018
Event Type  Injury  
Event Description
A report was received that the patient was experiencing inadequate stimulation.X-ray result showed that there were 2 contacts missing from the patients lead.The location of the missing contacts were unknown.
 
Manufacturer Narrative
Additional information was received that the x-ray confirmed that the lead was damaged.
 
Event Description
A report was received that the patient was experiencing inadequate stimulation.X-ray result showed that there were 2 contacts missing from the patients lead.The location of the missing contacts were unknown.
 
Manufacturer Narrative
Additional information was received that the location of the missing contacts were next to the leads.The patient will undergo a lead replacement procedure.
 
Event Description
A report was received that the patient was experiencing inadequate stimulation.X-ray result showed that there were 2 contacts missing from the patients lead.The location of the missing contacts were unknown.
 
Manufacturer Narrative
Additional information was received that the patient underwent a lead and ipg replacement procedure.The ipg was replaced per physicians preference.Device malfunction was suspected with the lead.The patient was doing well postoperatively.
 
Event Description
A report was received that the patient was experiencing inadequate stimulation.X-ray result showed that there were 2 contacts missing from the patients lead.The location of the missing contacts were unknown.
 
Manufacturer Narrative
Sc-8336-70/(b)(4) device evaluation indicated that the paddle damage was confirmed.Four electrodes were missing, and one of them was dislodged.Visual inspection found that the paddle silicone is torn at the junction and one tail appears pulled and it has exposed cables.Additionally, all four tails were clean cut.Clean cut damage is a result of a typical explant procedure and it is not considered a failure.
 
Event Description
A report was received that the patient was experiencing inadequate stimulation.X-ray result showed that there were 2 contacts missing from the patients lead.The location of the missing contacts were unknown.
 
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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 Key7199510
MDR Text Key97514322
Report Number3006630150-2018-00101
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729832676
UDI-Public08714729832676
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,Followup,Followup,Followup
Report Date 05/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/26/2019
Device Model NumberSC-8336-70
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/02/2018
Initial Date FDA Received01/17/2018
Supplement Dates Manufacturer Received01/17/2018
02/03/2018
03/09/2018
04/20/2018
Supplement Dates FDA Received02/02/2018
02/19/2018
03/29/2018
05/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2017
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 Outcome(s) Congenital Anomaly; Required Intervention;
Patient Age46 YR
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