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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-8336-50
Device Problems Unexpected Therapeutic Results (1631); Migration (4003)
Patient Problems Bacterial Infection (1735); Fever (1858); Inadequate Pain Relief (2388)
Event Date 10/23/2021
Event Type  Injury  
Event Description
It was reported that the patient was experiencing inadequate stimulation due to lead migration which was confirmed through an x ray. The patient developed a fever and was admitted to the hospital prior to the revision procedure. The patient went in the following day for a spinal cord stimulation lead revision surgery and was determined to have an infection at the incision site. The physician explanted the lead and the explanted lead will not be returned. The patient was put on antibiotics and was doing well postoperatively.
 
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Brand NameCOVEREDGE 32
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
road 698, lot no. 12
dorado PR 00646 -260
00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12930216
MDR Text Key282268006
Report Number3006630150-2021-06936
Device Sequence Number1
Product Code LGW
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 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-8336-50
Device Catalogue NumberSC-8336-50
Device Lot Number7075653
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2021
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: 12/03/2021 Patient Sequence Number: 1
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