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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION ARTISAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION ARTISAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-8216-70
Device Problems High impedance (1291); Device Dislodged or Dislocated (2923)
Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
Event Date 03/25/2021
Event Type  malfunction  
Manufacturer Narrative
Exact date unknown, event occurred a day prior from the date manufacturer became aware of the event.
 
Event Description
It was reported that the patient was experiencing inadequate stimulation as well as stimulation on a non target area due to high impedances which changes by posture.The patient was reprogrammed, however, unsuccessful.It was noted that the patient had multiple contacts that fell out of the paddle lead and it was confirmed that all the contacts were removed from the patients body.The patient underwent a lead replacement procedure and was doing well post-operatively.
 
Event Description
It was reported that the patient was experiencing inadequate stimulation as well as stimulation on a non target area due to high impedances which changes by posture.The patient was reprogrammed, however, unsuccessful.It was noted that the patient had multiple contacts that fell out of the paddle lead and it was confirmed that all the contacts were removed from the patients body.The patient underwent a lead replacement procedure and was doing well post-operatively.
 
Manufacturer Narrative
Sc-8216-70 sn: (b)(6).The returned lead was analyzed and revealed that the silicone at the paddle lead tails junction was torn and three electrodes were missing from the paddle end of the lead.This type of damage occurs when the lead is exposed to excessive tensile force causing the lead body to stretch and eventually break right at the paddle end.With all the available information, boston scientific concludes the reported event of high impedance was confirmed.The probabale cause is due to unintended use error which caused or contributed to the event.
 
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Brand Name
ARTISAN
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key11976019
MDR Text Key255420283
Report Number3006630150-2021-02826
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729779919
UDI-Public08714729779919
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/29/2021
Device Model NumberSC-8216-70
Device Catalogue NumberSC-8216-70
Device Lot Number7060532
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2021
Date Manufacturer Received06/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
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