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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION AVISTA MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION AVISTA MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2408-74
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Paralysis (1997); No Code Available (3191)
Event Date 07/04/2019
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model: sc-2408-74, serial/lot: (b)(4), description: avista mri perc lead kit 74 cm.
 
Event Description
A report was received that following the implant procedure the patient experienced leg paralysis symptoms.The physician switched off the stimulation and will continue to monitor.The physician does not believe that the symptoms are device related, but does not know the cause of the symptoms.During the procedure, the left side of the dura was punctured.The physician started refilling the infusion and punctured again.When placing the lead it was difficult to apply torque and did not enter the cervical spine, so a thoracic incision needle was inserted and the lead was placed at the tip pf c2.The patient now has feeling in the right leg but it is hard to get up and swelling has resolved.
 
Event Description
A report was received that following the implant procedure the patient experienced leg paralysis symptoms.The physician switched off the stimulation and will continue to monitor.The physician does not believe that the symptoms are device related, but does not know the cause of the symptoms.During the procedure, the left side of the dura was punctured.The physician started refilling the infusion and punctured again.When placing the lead it was difficult to apply torque and did not enter the cervical spine, so a thoracic incision needle was inserted and the lead was placed at the tip pf c2.The patient now has feeling in the right leg but it is hard to get up and swelling has resolved.
 
Manufacturer Narrative
Additional information was received the edema was located in the spine of the patient.
 
Event Description
A report was received that following the implant procedure the patient experienced leg paralysis symptoms.The physician switched off the stimulation and will continue to monitor.The physician does not believe that the symptoms are device related, but does not know the cause of the symptoms.During the procedure, the left side of the dura was punctured.The physician started refilling the infusion and punctured again.When placing the lead it was difficult to apply torque and did not enter the cervical spine, so a thoracic incision needle was inserted and the lead was placed at the tip pf c2.The patient now has feeling in the right leg but it is hard to get up and swelling has resolved.
 
Manufacturer Narrative
Age: 75 years.Additional information was received that following the implant procedure the patient experienced edema and was only able to bend and stretch the right leg.The patient continues rehabilitation and is recovering.
 
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Brand Name
AVISTA MRI
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 Key8803876
MDR Text Key151474825
Report Number3006630150-2019-03673
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729904823
UDI-Public08714729904823
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,distri
Type of Report Initial,Followup,Followup
Report Date 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/25/2020
Device Model NumberSC-2408-74
Device Catalogue NumberSC-2408-74
Device Lot Number5076929
Was Device Available for Evaluation? No
Date Manufacturer Received08/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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