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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 Telemetry Discrepancy (1629); Device Inoperable (1663); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2017
Event Type  malfunction  
Event Description
A report was received that the patient was having telemetry issues and difficulty charging the ipg.It was also noted that the scs was non-functional.The patient will undergo an ipg replacement procedure.
 
Manufacturer Narrative
Additional information was received that the patient was also experiencing communication issues with the ipg.The patient underwent an ipg replacement procedure.Device malfunction was suspected.The patient was doing well postoperatively.The explanted device was not returned to bsn as it was discarded 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 was having telemetry issues and difficulty charging the ipg.It was also noted that the scs was non-functional.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 Key6737099
MDR Text Key80834909
Report Number3006630150-2017-02684
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767688
UDI-Public(01)08714729767688(17)140601(10)15925557
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 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2017
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 Received08/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2013
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 Age46 YR
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