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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-1200-S
Device Problems Premature Discharge of Battery (1057); High impedance (1291); Unexpected Therapeutic Results (1631); Application Program Problem (2880); Wireless Communication Problem (3283)
Patient Problem No Code Available (3191)
Event Date 05/14/2020
Event Type  malfunction  
Event Description
It was reported that during a procedure to add a right dbs lead the representative noticed unusual lead impedances and a dead ipg.The ipg would not communicate with the remote control or the clinician programmer.The physician replaced the ipg with a new one.The patient was doing well with good stimulation post operatively, and all impedances normalized.
 
Manufacturer Narrative
Device technical analysis: visual inspection of the returned ipg revealed the device could not be charged nor linked even with an external power source due to asic u3 damage caused by high-voltage transients or high rf energy during the reported procedure.Investigation conclusion: the investigation concluded that the reported event of unusual lead impedances and a dead ipg, and both a plasma blade and bipolar cautery were used during the case but not at the battery site was confirmed through device analysis.Therefore the most probable root cause is traced to unintended use error caused or contributed to event.
 
Event Description
It was reported that during a procedure to add a right dbs lead the representative noticed unusual lead impedances and a dead ipg.The ipg would not communicate with the remote control or the clinician programmer.The physician replaced the ipg with a new one.The patient was doing well with good stimulation post operatively, and all impedances normalized.
 
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Brand Name
VERCISE GEVIA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key10123569
MDR Text Key194147786
Report Number3006630150-2020-02355
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729984443
UDI-Public08714729984443
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/05/2020
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 Date12/07/2021
Device Model NumberDB-1200-S
Device Catalogue NumberDB-1200-S
Device Lot Number741244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2020
Initial Date Manufacturer Received 05/14/2020
Initial Date FDA Received06/05/2020
Supplement Dates Manufacturer Received08/03/2020
Supplement Dates FDA Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age88 YR
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