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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION ENTRADA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION ENTRADA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-4220-45
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Paralysis (1997); Numbness (2415)
Event Date 03/04/2022
Event Type  Injury  
Event Description
It was reported during the implant procedure the physician was entering using the needle and hit a nerve root on the left side causing the patient to lose sensation and motor function in her left leg therefore the trial was aborted.The patient regained full sensation and motor function in the left leg.It was also noted that strength and numbness had significantly improved but patient was still experiencing pain in the leg and admitted herself into the hospital.The entrada needle was discarded by medical facility.
 
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Brand Name
ENTRADA
Type of Device
STIMULATOR, 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
4100 hamline avenue north
saint paul MN 55112 5798
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key13865602
MDR Text Key287830719
Report Number3006630150-2022-01178
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729950684
UDI-Public08714729950684
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/10/2022
Device Model NumberSC-4220-45
Device Catalogue NumberSC-4220-45
Device Lot Number27415042
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2022
Initial Date FDA Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age39 YR
Patient SexFemale
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