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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-8352-70
Device Problems Difficult to Remove (1528); Unexpected Therapeutic Results (1631)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.
 
Event Description
It was reported that the patients old paddle was up too high from where the trial was years ago and was also not getting adequate pain relief.The physician initially planned to replace the whole system but was unable to get the old paddle out, and therefore left the paddle lead and cut the tails off.
 
Event Description
It was reported that the patients old paddle was up too high from where the trial was years ago and was also not getting adequate pain relief.The physician initially planned to replace the whole system but was unable to get the old paddle out, and therefore left the padldle lead and cut the tails off.Additional information was received that the lead was explanted and returned.
 
Manufacturer Narrative
Sc-8352-70 (b)(6).The returned paddle lead was analyzed, and the lead was cleanly cut, and the paddle was not returned.No anomalies were identified on the lead aside from the clean-cut.The damage to the lead is a result of a typical explant procedure, and it is not considered a failure.
 
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Brand Name
COVEREDGE X 32
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key11840071
MDR Text Key251096462
Report Number3006630150-2021-02178
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729832690
UDI-Public08714729832690
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/16/2017
Device Model NumberSC-8352-70
Device Catalogue NumberSC-8352-70
Device Lot Number18712843
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2021
Date Manufacturer Received06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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