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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 Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
Patient Problems Paralysis (1997); Urinary Incontinence (4572)
Event Date 05/21/2021
Event Type  Injury  
Event Description
It was reported that the patient had loss of sensation in her legs, was having urinary issues following an implant procedure, and was sent back to the hospital. The patient reported that she has been in the hospital receiving rehabilitation and physical therapy twice a day since the implant procedure. She also stated that the doctors at the hospital do not know why she is experiencing these symptoms post implant. An magnetic resonance imaging (mri) was performed, however it did not show anything. Upon follow up the patient reported that her legs are getting better, but she is nowhere near where she was prior to the surgery. She reported that she is not releasing all urine, and is still retaining 30-50 percent. It was also stated that the patient was experiencing overstimulation. The patients physician does not know the cause of the patients symptoms, and reported that nothing happened during the recent procedure that may have caused or contributed to the issue. It was noted that post-implant the patient had all movement and was able to walk and use the bathroom.
 
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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 Key12012532
MDR Text Key256720852
Report Number3006630150-2021-02994
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
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 Number7072350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2020
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: 06/16/2021 Patient Sequence Number: 1
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