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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 Device Inoperable (1663); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 05/09/2018
Event Type  Injury  
Event Description
A report was received that the patient will undergo an ipg revision procedure for an unknown reason.
 
Manufacturer Narrative
Additional information was received that the patients ipg was at its end of life.The patient underwent an ipg replacement procedure and was doing well postoperatively.No device malfunction was suspected.The explanted device was not returned to bsn as it was discarded by the medical facility.
 
Event Description
A report was received that the patient will undergo an ipg revision procedure for an unknown reason.
 
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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 Key7554386
MDR Text Key109572179
Report Number3006630150-2018-01921
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767688
UDI-Public08714729767688
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 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2010
Device Model NumberSC-1110-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/09/2018
Initial Date FDA Received05/30/2018
Supplement Dates Manufacturer Received05/29/2018
Supplement Dates FDA Received06/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2009
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 Outcome(s) Required Intervention;
Patient Age43 YR
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