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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-8216-50
Device Problems High impedance (1291); Component Missing (2306); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 02/14/2018
Event Type  Injury  
Event Description
A report was received that there were high impedances on both sides of the patients lead.X-ray was taken and revealed contacts popping out of the lead.It was noted that there were missing contacts and some could not be seen on x-ray.
 
Manufacturer Narrative
Additional information was received that twelve contacts were removed and four remains inside the body.The physician did not feel it was safe to remove the remaining contacts.
 
Event Description
A report was received that there were high impedances on both sides of the patients lead.X-ray was taken and revealed contacts popping out of the lead.It was noted that there were missing contacts and some could not be seen on x-ray.
 
Manufacturer Narrative
Additional information was received that the patient underwent a revision procedure wherein the lead and ipg was replaced.Database analysis confirmed high impedances on ports c and d.The patient was doing well postoperatively.
 
Event Description
A report was received that there were high impedances on both sides of the patients lead.X-ray was taken and revealed contacts popping out of the lead.It was noted that there were missing contacts and some could not be seen on x-ray.
 
Manufacturer Narrative
Sc-8216-50 (sn: (b)(4)) device evaluation indicated that the complaint has been confirmed.Visual inspection revealed that 12 electrodes were completely dislodged from the paddle and 10 were not returned.Electrodes # 4, 11, 12 and 13 are not dislodged from the paddle.The paddle is torn right at the midsection.Damage to the paddle suggests that excessive tensile force was exerted onto the lead bodies resulting in dislodged electrodes and torn paddle.Additionally, the lead bodies were cleanly cut.The 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 there were high impedances on both sides of the patients lead.X-ray was taken and revealed contacts popping out of the lead.It was noted that there were missing contacts and some could not be seen on x-ray.
 
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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 Key7332307
MDR Text Key102159185
Report Number3006630150-2018-00928
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729779902
UDI-Public08714729779902
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
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/01/2018
Device Model NumberSC-8216-50
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2017
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) Required Intervention;
Patient Age66 YR
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