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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-9218-15
Device Problems High impedance (1291); Defective Device (2588)
Patient Problems Shaking/Tremors (2515); No Code Available (3191)
Event Date 03/22/2019
Event Type  Injury  
Manufacturer Narrative
Implant date: (b)(6) 2018.Additional suspect medical device components involved: reference number: 10890375, product family: dbs-adapters, upn: (b)(4), model: db-9218-15.
 
Event Description
A report was received that a patient who is severely bradykinetic and has right sided tremors started experiencing these symptoms while watching tv and had no unusual activities or medical exams.The patient had to be admitted to the hospital.The bsn representative met with the patient in the hospital and tried reprogramming the patient but the patient's symptoms were not resolved.The neurologist noticed high impedances on the right lead which did not correspond to the side of the body where the patient's symptoms are.The impedance measurements are normal on the side (left) where the patient's symptoms are being exhibited.The patient is implanted with two competitor leads and two bsc adaptors.The patient had a ct scan to confirm that the leads did not move.The patient's ipg database was analyzed and found high impedances on contacts 5 through 8 due to the lack of connection from a competitor's device.The ipg's charging profile was normal.The database showed only 1 magnet reset, otherwise the ipg is working correctly.The patient underwent a surgery to investigate the system.The bsc adaptors and the competitor leads were replaced.The ipg remains implanted.The patient has shown improved symptoms after the surgery.
 
Event Description
A report was received that a patient who is severely bradykinetic and has right sided tremors started experiencing these symptoms while watching tv and had no unusual activities or medical exams.The patient had to be admitted to the hospital.The bsn representative met with the patient in the hospital and tried reprogramming the patient but the patient's symptoms were not resolved.The neurologist noticed high impedances on the right lead which did not correspond to the side of the body where the patient's symptoms are.The impedance measurements are normal on the side (left) where the patient's symptoms are being exhibited.The patient is implanted with two competitor leads and two bsc adaptors.The patient had a ct scan to confirm that the leads did not move.The patient's ipg database was analyzed and found high impedances on contacts 5 through 8 due to the lack of connection from a competitor's device.The ipg's charging profile was normal.The database showed only 1 magnet reset, otherwise the ipg is working correctly.The patient underwent a surgery to investigate the system.The bsc adaptors and the competitor leads were replaced.The ipg remains implanted.The patient has shown improved symptoms after the surgery.
 
Manufacturer Narrative
The complaint was not confirmed.Device analysis performed on both of the returned adapters passed all tests performed.Correction of the initial mdr.Implant date (b)(6)2018.Additional suspect medical device components involved: reference number: (b)(4).Product family: dbs-adapters.Upn: m365db9218150.Model: db-9218-15.Serial: (b)(4).Batch: 20232527.
 
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Brand Name
VERCISE
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key8524646
MDR Text Key142270847
Report Number3006630150-2019-01730
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 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/02/2019
Device Model NumberDB-9218-15
Device Catalogue NumberDB-9218-15
Device Lot Number20232527
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2019
Date Manufacturer Received05/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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