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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 Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)
Patient Problems Pain (1994); Swelling (2091)
Event Date 09/07/2017
Event Type  Injury  
Event Description
A report was received that the patient was experiencing pain at the ipg site. Redness, swelling, and tender to the touch was also noted. The physician believed that the pain might be due to the battery moving a little bit. The patient was prescribed with abdominal binder to help the healing process. No actual skin breakage was noted. The patient will be getting pain medication management by their family physician.
 
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Brand NamePRECISION SPECTRA
Type of DeviceSPINAL 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 Key6951340
MDR Text Key89372450
Report Number3006630150-2017-04007
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/26/2019
Device Model NumberSC-1132
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/16/2017 Patient Sequence Number: 1
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