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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 Wireless Communication Problem (3283)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/27/2018
Event Type  Injury  
Event Description
A report was received that the patient had some connectivity issue with the ipg. The patient will undergo an ipg replacement procedure.
 
Manufacturer Narrative
Additional information was received that the patient underwent an ipg replacement procedure. The patient was doing well postoperatively. 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 related to the event occurred during manufacturing.
 
Event Description
A report was received that the patient had some connectivity issue with the ipg. 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 NEUROMODULATION CORPORATION
25129 rye canyon loop
,
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7717195
MDR Text Key114930275
Report Number3006630150-2018-60344
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 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/17/2016
Device Model NumberSC-1110-02
Device Catalogue NumberSC-1110-02
Device Lot Number16620782
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 Received08/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2014
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: 07/24/2018 Patient Sequence Number: 1
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