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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-1132
Device Problems Charging Problem (2892); Material Protrusion/Extrusion (2979)
Patient Problem Discomfort (2330)
Event Date 08/09/2017
Event Type  Injury  
Event Description
A report was received that the patient was having difficulty charging the ipg.It was also noted that the ipg site was protruding and causing some discomfort after a weight loss.There was no skin breakage.The patient will undergo an ipg replacement procedure.
 
Manufacturer Narrative
Additional information was received that the patient underwent an ipg replacement procedure.No device malfunction was suspected.The patient was doing well postoperatively.The explanted device was not returned to bsn.
 
Event Description
A report was received that the patient was having difficulty charging the ipg.It was also noted that the ipg site was protruding and causing some discomfort after a weight loss.There was no skin breakage.The patient will undergo an ipg replacement procedure.
 
Manufacturer Narrative
Additional information was received that the physician did not believe that the charging difficulty was due to weight loss.No further course of action will be taken at this time.
 
Event Description
A report was received that the patient was having difficulty charging the ipg.It was also noted that that the ipg site was protruding and causing some discomfort after a weight loss.There was no skin breakage.The patient will undergo an ipg replacement procedure.
 
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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 Key6894072
MDR Text Key87354967
Report Number3006630150-2017-03540
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public08714729821526
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
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/05/2017
Device Model NumberSC-1132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2015
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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