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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION®; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION®; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1110-02
Device Problems Failure to Charge (1085); Telemetry Discrepancy (1629); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2016
Event Type  malfunction  
Event Description
A report was received that the patient had telemetry issues.It was also noted that the patient's ipg was no longer functional and would no longer charge after a non-device related procedure using a defibrillator.Device malfunction was suspected.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 as it was kept by the medical facility.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
 
Event Description
A report was received that the patient had telemetry issues.It was also noted that the patient's ipg was no longer functional and would no longer charge after a non-device related procedure using a defibrillator.Device malfunction was suspected.The patient will undergo an ipg replacement procedure.
 
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Brand Name
PRECISION®
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 Key6327523
MDR Text Key67319879
Report Number3006630150-2017-00430
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767688
UDI-Public(01)08714729767688(17)140601(10)15316576
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
Report Date 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/01/2014
Device Model NumberSC-1110-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2012
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 Age83 YR
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