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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
Model Number DB-2201-45DC
Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)
Patient Problems Fall (1848); Pain (1994)
Event Date 12/18/2019
Event Type  malfunction  
Event Description
It was reported that the deep brain stimulation (dbs) patient fell and experienced lateralization of the body to the left, intense pain in the right clavicular region and no further improvement in therapy.High impedances were observed on the dbs leads which is associated with a partial rupture of the right electrode.The patient will undergo a revision procedure.Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2201-45dc, serial: n/i, batch: n/i.
 
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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
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key10053663
MDR Text Key194377616
Report Number3006630150-2020-02054
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDB-2201-45DC
Device Catalogue NumberDB-2201-45DC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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