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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION LINEAR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2158-70
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/07/2022
Event Type  Injury  
Event Description
It was reported that the patients leads in the cervical area were not getting coverage on the left due to location on the far right. The patient underwent a lead replacement procedure and repositioned at the midline. The patient was doing well post-operatively. The explanted leads will not be returned per physician preference.
 
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event. Additional suspect medical device components involved in the event: product family: scs-linear leads, upn:(b)(4), model: sc-2158-70, serial: (b)(4), batch: (b)(4). Upn:(b)(4), model: sc-2158-50, serial: (b)(4), batch: (b)(4).
 
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Brand NameLINEAR
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 Key15141964
MDR Text Key297031556
Report Number3006630150-2022-03780
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767718
UDI-Public08714729767718
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 08/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2012
Device Model NumberSC-2158-70
Device Catalogue NumberSC-2158-70
Device Lot Number13857616
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2010
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: 08/01/2022 Patient Sequence Number: 1
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