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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 Problems Failure to Charge (1085); Device Inoperable (1663); Defective Device (2588)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 04/16/2018
Event Type  malfunction  
Event Description
A report was received that the patient was not charging and non-functional. The patient will undergo an ipg replacement procedure.
 
Manufacturer Narrative
Additional information was received that the patient underwent an ipg replacement procedure and was doing well postoperatively. The explanted device was not returned to bsn a review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing.
 
Event Description
A report was received that the patient was not charging and non-functional. The patient will undergo an ipg replacement procedure.
 
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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 Key7546204
MDR Text Key109312084
Report Number3006630150-2018-01823
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 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2009
Device Model NumberSC-1110-02
Device Catalogue NumberSC-1110-02
Device Lot Number181434
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 Received12/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2008
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: 05/25/2018 Patient Sequence Number: 1
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