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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-2202-30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Speech Disorder (4415); Swelling/ Edema (4577)
Event Date 12/01/2020
Event Type  Injury  
Event Description
It was reported that the patient experienced a mild word finding disorder.The patient was treated with antibiotics and the event is resolving.The event was assessed with a causal relationship to the procedure and not device or stimulation related.
 
Event Description
It was reported that the patient experienced a mild word finding disorder.The patient was treated with antibiotics and the event is resolving.The event was assessed with a causal relationship to the procedure and not device or stimulation related.Additional information was received that on 01dec2020 the patient had edema around the left electrode with word finding disorders.The event was assessed with a causal relationship to the procedure and not device or stimulation related.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads upn: m365db2202450 model: db-2202-45 serial: (b)(6).Batch: 7072229 correction to initial mdr in block d1 and d4.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, (b)(6).
 
Event Description
It was reported that the patient experienced a mild word finding disorder.The patient was treated with antibiotics and the event is resolving.The event was assessed with a causal relationship to the procedure and not device or stimulation related.Additional information was received that on (b)(6) 2020 the patient had edema around the left electrode with word finding disorders.The event was assessed with a causal relationship to the procedure and not device or stimulation related.
 
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Brand Name
VERCISE CARTESIA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key11069882
MDR Text Key223580472
Report Number3006630150-2020-06388
Device Sequence Number1
Product Code NHL
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,Followup
Report Date 03/26/2021
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 Lay User/Patient
Device Expiration Date09/09/2022
Device Model NumberDB-2202-30
Device Catalogue NumberDB-2202-30
Device Lot Number7072229
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received01/19/2021
03/01/2021
Supplement Dates FDA Received02/11/2021
03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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