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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-1110-02
Device Problem Defective Device (2588)
Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Seroma (2069); No Code Available (3191)
Event Date 01/16/2020
Event Type  Injury  
Manufacturer Narrative
The explanted device was not returned to bsn as it was kept by the medical facility. A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially relate to the event occurred during manufacturing. A review of the sterilization documentation for the ipg was found to be satisfactory.
 
Event Description
A report was received that the patients ipg was nonfunctional. It was noted that patient initially had an infection at the ipg site. The patient underwent an ipg replacement procedure and was doing well postoperatively.
 
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Brand NamePRECISION
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key9672519
MDR Text Key177837275
Report Number3006630150-2020-00390
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2011
Device Model NumberSC-1110-02
Device Catalogue NumberSC-1110-02
Device Lot Number190094
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2009
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: 02/05/2020 Patient Sequence Number: 1
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