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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 Problems Unexpected Therapeutic Results (1631); Delayed Charge Time (2586); Charging Problem (2892)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/23/2021
Event Type  Injury  
Manufacturer Narrative
Event date: exact date unknown, event occurred approximately three months ago from date the manufacturer became aware of the event.
 
Event Description
It was reported that the patient was not getting an adequate pain relief. It was also noted that the patients ipg had to be charged frequently and for a long period of time. The patient underwent a revision procedure where two leads were added and the ipg was replaced. The patient was doing well post-operatively. The explanted ipg will not be returned as it was discarded by the medical facility.
 
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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 CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key15235429
MDR Text Key297991632
Report Number3006630150-2022-04086
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767688
UDI-Public08714729767688
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2013
Device Model NumberSC-1110-02
Device Catalogue NumberSC-1110-02
Device Lot Number14405206
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2011
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: 08/16/2022 Patient Sequence Number: 1
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