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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1112
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pocket Erosion (2013); Staphylococcus Aureus (2058); Swelling (2091); No Code Available (3191)
Event Date 08/15/2019
Event Type  Injury  
Manufacturer Narrative
The ipg has not been returned to bsn.A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
 
Event Description
A report was received that the patient experienced effacement of the ipg and may have had an underlying staph infection.The patient underwent and ipg explant procedure.
 
Manufacturer Narrative
Additional information was received that there may have been a low grade infection at the ipg site as the patient was continually having pain and intermittent swelling there.However, microbiology results showed no growth.The patient was also administered amoxicillin for seven days.The event was assessed as not device related.
 
Event Description
A report was received that the patient experienced effacement of the ipg and may have had an underlying staph infection.The patient underwent and ipg explant procedure.
 
Event Description
A report was received that the patient experienced effacement of the ipg and may have had an underlying staph infection.The patient underwent and ipg explant procedure.
 
Manufacturer Narrative
Additional information was received that there may have been a low grade infection at the ipg site as the patient was continually having pain and intermittent swelling there.However, microbiology results showed no growth.The patient was also administered amoxicillin for seven days.The event was assessed as not device related.The returned lpg was analyzed, passed all required tests performed, and exhibited normal device characteristics.The root cause of the complaint could not be determined.
 
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Brand Name
PRECISION
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 Key8978254
MDR Text Key157028875
Report Number3006630150-2019-04916
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729837138
UDI-Public08714729837138
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,foreig
Type of Report Initial,Followup,Followup
Report Date 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2017
Device Model NumberSC-1112
Device Catalogue NumberSC-1112
Device Lot Number17556709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2019
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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