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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problems Visual Disturbances (2140); No Code Available (3191)
Event Date 01/12/2020
Event Type  Injury  
Manufacturer Narrative
Date of implant: (b)(6) 2017 (exact date is unknown).
 
Event Description
It was reported that the patient experienced double vision following the activation of the dbs lead stimulation.An mri, magnetic resonance imaging, confirmed that the lead was 4mm too deep.The patient underwent a lead revision procedure three months post the initial implant in which the lead was repositioned.The patient indicated that the stimulation was then working, but that if the stimulation was increased it would cause pain on the sole of the left foot.A second mri, magnetic resonance imaging, confirmed that the right lead was not positioned well.No other information is available at this time.
 
Event Description
It was reported that the patient experienced double vision following the activation of the dbs lead stimulation.An mri, magnetic resonance imaging, confirmed that the lead was 4mm too deep.The patient underwent a lead revision procedure three months post the initial implant in which the lead was repositioned.The patient indicated that the stimulation was then working, but that if the stimulation was increased it would cause pain on the sole of the left foot.A second mri, magnetic resonance imaging, confirmed that the right lead was not positioned well.No other information is available at this time.Additional information was received that the patient was implant in (b)(6) 2017 of the cartesia lead db-2202, the exact model and the serial numbers are unknown, the revision took place in (b)(6) 2017.The patient is doing well postoperatively.The model and serial number of the device is unknown therefore, a record review could not be performed.The device remains implanted and will not be returned for evaluation; therefore, a technical product analysis of the device could not be completed.
 
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Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key9795692
MDR Text Key182294554
Report Number3006630150-2020-01020
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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