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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-2202-45
Device Problems Unexpected Therapeutic Results (1631); Migration (4003)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, serial: (b)(4), lot: 5149217.Product family: dbs-ipg-r-mri, upn: (b)(4), model: db-1200, serial: (b)(4), lot: 738942.
 
Event Description
It was reported that the deep brain stimulation patient experienced a loss of therapeutic effect for several weeks.X-rays revealed that the leads migrated.The patient underwent a lead revision procedure, however, during the procedure, the ipg was found to be depleted, therefore, the physician charged the ipg during the procedure which allowed him to check the impedances.At the end of the procedure, the lead was connected to the ipg and impedances were displayed when the lead was both connected and disconnected.It was discovered that the remote control and the computer programmer were unable to connect with the ipg.The physician chose to remove and replace both leads, however, the ipg was left in the patient.The patient then underwent another procedure on (b)(6) 2020 where the ipg was replaced.The leads will not be returned as they were disposed of by the medical facility.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), lot: (b)(6).Product family: dbs-ipg-r-mri, upn: m365db12000, model: db-1200, serial: (b)(6), lot: (b)(6).The leads were not returned for analysis.A product labeling review identified that the leads were used per the directions for use (dfu) / product label.Additionally, lead migration is noted within the dfu as a potential risk associated with the use of the device.The physician noted that the x-rays revealed the leads had migrated which caused a loss of therapeutic effect.Per the labelling review, loss of adequate stimulation and lead migration is a known risk with the use of deep brain stimulation.The returned ipg was analyzed and confirmed that it was undetectable to the remote control and computer programmer and could not be charged.The battery was replaced by an external power source for further investigation.The device exhibited excessive sleep current leakage, low high voltage (vh) impedance, and a hot spot on u2 asic.The ipgs system data log was obtained using an external power source and it revealed that the device was working normally prior to the revision procedure, which suggests the device was damaged during the revision procedure.Based on all available information, engineers concluded that the ipg had worked fine up to the procedure and was likely damaged during the revision procedure.
 
Event Description
It was reported that the deep brain stimulation patient experienced a loss of therapeutic effect for several weeks.X-rays revealed that the leads migrated.The patient underwent a lead revision procedure, however, during the procedure, the ipg was found to be depleted, therefore, the physician charged the ipg during the procedure which allowed him to check the impedances.At the end of the procedure, the lead was connected to the ipg and impedances were displayed when the lead was both connected and disconnected.It was discovered that the remote control and the computer programmer were unable to connect with the ipg.The physician chose to remove and replace both leads, however, the ipg was left in the patient.The patient then underwent another procedure on (b)(6) 2020 where the ipg was replaced.The leads will not be returned as they were disposed of by the medical facility.
 
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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 Key11083752
MDR Text Key224132861
Report Number3006630150-2020-06441
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729905288
UDI-Public08714729905288
Combination Product (y/n)N
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 03/08/2021
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? Yes
Device Operator Lay User/Patient
Device Expiration Date05/15/2021
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number5149233
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/13/2020
Initial Date FDA Received12/28/2020
Supplement Dates Manufacturer Received02/12/2021
Supplement Dates FDA Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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