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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-1140
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Dysphagia/ Odynophagia (1815); Pneumonia (2011)
Event Date 07/19/2022
Event Type  Injury  
Event Description
It was reported the patient, who was implanted with a deep brain stimulator had lost therapy as their implantable pulse generator, ipg, became empty.The patient was hospitalized because of the severe symptoms that came back after stimulation was interrupted.Due to the loss of deep brain stimulation therapy, the patient developed motor performance decline, severe bradykinesia and rigidity, swallowing problem and pneumonia.There was no indication that the ipg or remote control was not functioning properly.The patients caregiver had checked the ipg approximately fifteen days prior to the event without notice of an elective replacement indicator, eri, message.The symptoms evolved for 24-48 hours and then remained stable.A certain degree of parkinsonian symptoms were related to other medical condition, i.E.Infection.The patient underwent a revision procedure in which the ipg was replaced.The patient was administered antibiotics and her medication was adjusted.The patient is gradually getting better.
 
Manufacturer Narrative
Engineers inspected and analyzed the returned device db-1140, serial (b)(6), the ipg was confirmed to have reached end of service, eos mode.After the elective replacement indicator, eri was displayed, the device continued to provide therapy as expected.It was confirmed that the device had functioned for 52 months when the eri was activated.The ipg then then functioned an additional four months following the eri message and before reaching the eos in (b)(6) 2022.The device was in service for a total of 56 months.The devices longevity was within the expected range of 44 months, per product labeling.A review of the patient data revealed no anomalies.Laboratory analysis of the returned device did not reveal any anomalies.It had been reported that the patients caregiver checked the ipg approximately fifteen days prior to the eos without noticing the eri message.Engineers confirmed the eos indicator was seen on an equivalent remote control during laboratory testing, indicating the mechanism for sending eri-eos messages from the ipg to remote control was functioning properly.Although the specific cause of the complaint could not be confirmed, in this case engineers believe that user error likely caused them to miss seeing the eri message.Therefore, engineers have determined that the likely cause of not noticing the eri message was due to an unintended user error.
 
Event Description
It was reported the patient, who was implanted with a deep brain stimulator had lost therapy as their implantable pulse generator, ipg, became empty.The patient was hospitalized because of the severe symptoms that came back after stimulation was interrupted.Due to the loss of deep brain stimulation therapy, the patient developed motor performance decline, severe bradykinesia and rigidity, swallowing problem and pneumonia.There was no indication that the ipg or remote control was not functioning properly.The patients caregiver had checked the ipg approximately fifteen days prior to the event without notice of an elective replacement indicator, eri, message.The symptoms evolved for 24-48 hours and then remained stable.A certain degree of parkinsonian symptoms were related to other medical condition, i.E.Infection.The patient underwent a revision procedure in which the ipg was replaced.The patient was administered antibiotics and her medication was adjusted.The patient is gradually getting better.Additional information was received that after the patient was hospitalized in the neurology department, she was then transferred to a clinic for neurological rehabilitation.The patient was returned to the home for the elderly at a later date.
 
Event Description
It was reported the patient, who was implanted with a deep brain stimulator had lost therapy as their implantable pulse generator, ipg, became empty.The patient was hospitalized because of the severe symptoms that came back after stimulation was interrupted.Due to the loss of deep brain stimulation therapy, the patient developed motor performance decline, severe bradykinesia and rigidity, swallowing problem and pneumonia.There was no indication that the ipg or remote control was not functioning properly.The patients caregiver had checked the ipg approximately fifteen days prior to the event without notice of an elective replacement indicator, eri, message.The symptoms evolved for 24-48 hours and then remained stable.A certain degree of parkinsonian symptoms were related to other medical condition, i.E.Infection.The patient underwent a revision procedure in which the ipg was replaced.The patient was administered antibiotics and her medication was adjusted.The patient is gradually getting better.
 
Manufacturer Narrative
Model db-1140, serial number (b)(6): engineers inspected and analyzed the returned device and the ipg was confirmed to have reached eos, end of service mode.After the elective replacement indicator, eri was displayed, the device continued to provide therapy and functioned for 23 days.The device was in service for a total of 52 months.The devices longevity was within the expected range of 44 months per product labeling.Laboratory analysis of the returned device did not reveal any anomalies.
 
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Brand Name
VERCISE PC
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key15255234
MDR Text Key298197267
Report Number3006630150-2022-04162
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/12/2019
Device Model NumberDB-1140
Device Catalogue NumberDB-1140
Device Lot Number20744212
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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