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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA®; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA®; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1132
Device Problems Telemetry Discrepancy (1629); Charging Problem (2892)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2017
Event Type  malfunction  
Event Description
A report was received that the patient had difficulty charging the ipg.It was noted that the charging difficulty was due to ipg location and also having telemetry issue.The patient will undergo an ipg replacement procedure.
 
Manufacturer Narrative
Additional information was received that the patient was able to charge the ipg.No further course of action at this time.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 difficulty charging the ipg.It was noted that the charging difficulty was due to ipg location and also having telemetry issue.The patient will undergo an ipg replacement procedure.
 
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Brand Name
PRECISION SPECTRA®
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 Key6350512
MDR Text Key68085833
Report Number3006630150-2017-00534
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public(01)08714729821526(17)180914(10)19717555
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 01/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/14/2018
Device Model NumberSC-1132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2016
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 Age84 YR
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