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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 Fracture (1260); Unexpected Therapeutic Results (1631); Migration (4003)
Patient Problems Inadequate Pain Relief (2388); Implant Pain (4561)
Event Date 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
Exact date unknown, event occurred two weeks after the date of implant. Additional suspect medical device component involved in the event: product family: scs-ipg-r-mri upn: m365sc12320. Model: sc-1232. Serial: (b)(4). Batch: 512936.
 
Event Description
It was reported that the patient was experiencing pain at the lead site, inadequate stimulation and loss of stimulation due to lead migration. X-ray was taken and showed that the paddle lead had ripped into two and was completely out of epidural space. It was also noted that the ends of the wires pulled out of the ipg. The patient had a non-device related hard fall after the implant surgery. Reprogramming was attempted, however, unsuccessful. The patient underwent a revision procedure wherein the paddle lead and ipg were replaced. The patient was doing well post-operatively and the explanted devices were discarded.
 
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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 Key12356127
MDR Text Key267757493
Report Number3006630150-2021-04707
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 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC-8336-50
Device Catalogue NumberSC-8336-50
Device Lot Number7072046
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 Received08/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2020
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: 08/23/2021 Patient Sequence Number: 1
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