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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Paralysis (1997); Thrombosis/Thrombus (4440)
Event Date 03/01/2021
Event Type  Injury  
Event Description
It was reported that within the week following a spinal cord stimulator scs implant procedure, the patient was admitted to the hospital due to shortness of breath and coughing. A couple days later, the patient developed loss a of sensation in the legs. The patient's scs was working as expected, however, the device was turned off due to the event. The physician confirmed that the patient had a blood clot, therefore, the patient underwent a procedure where the paddle lead was explanted and the ipg was left implanted. The physician assessed that the patient's pre-existing congestive heart failure chf condition caused the coughing attack that led the patient to go to the emergency department and this coughing propelled the blood clot. Post-operatively, the patient felt improved strength in the legs, went back on blood thinners, and is recovering. The lead will not be returned.
 
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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 Key11572043
MDR Text Key242386243
Report Number3006630150-2021-01217
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 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
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 Number7070293
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 Received03/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2019
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: 03/25/2021 Patient Sequence Number: 1
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