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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-8352-50
Device Problem High impedance (1291)
Patient Problems Incontinence (1928); No Consequences Or Impact To Patient (2199); Numbness (2415)
Event Date 09/14/2018
Event Type  Injury  
Event Description
A report was received that the patient had high impedance on contact c1 during a programming session.The patient experienced symptoms such as not being able to feel her belly and urinating in her bed the previous night.The patient will undergo another reprogramming session.
 
Manufacturer Narrative
A review of the manufacturing documentation for the lead sc-8352-50 (serial number: (b)(4) revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.Additional information was received that the patient is doing well and happy with her stimulation parameters.
 
Event Description
A report was received that the patient had high impedance on contact c1 during a programming session.The patient experienced symptoms such as not being able to feel her belly and urinating in her bed the previous night.The patient will undergo another reprogramming session.
 
Manufacturer Narrative
Additional information was received that the patient's symptoms were not stimulation related.The patient is doing well post-operatively and does not have the reported symptoms.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/27/2018 10:44 am ct.The report number is being corrected from: 3006630150-2018-62494to: 3006630150-2018-61323.
 
Event Description
A report was received that the patient had high impedance on contact c1 during a programming session.The patient experienced symptoms such as not being able to feel her belly and urinating in her bed the previous night.The patient will undergo another reprogramming session.
 
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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 Key7958260
MDR Text Key123450980
Report Number3006630150-2018-61323
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729832683
UDI-Public08714729832683
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,foreig
Type of Report Initial,Followup,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/03/2020
Device Model NumberSC-8352-50
Device Catalogue NumberSC-8352-50
Device Lot Number7006722
Was Device Available for Evaluation? No
Date Manufacturer Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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