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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSYPKA AG VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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OSYPKA AG VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-9418-15
Device Problems High impedance (1291); Defective Device (2588)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2020
Event Type  Injury  
Event Description
It was reported that the patient experienced high impedances and underwent a procedure to confirm if the pocket adapter or the non-boston scientific lead extension was the cause of high impedances.During the procedure, the physician attempted to use a torque wrench to remove the screw to disconnect the adapter from the non-boston scientific lead extension, however, the adapter screw was unable to be removed.The physician then attempted to use the correct wrench, various other wrenches, rubber pads and scissors but was still unable to remove the screw which had then been flattened and damaged.The physician then pulled the non-boston scientific lead extension from the adapter and separated the devices.The lead adapter and the non-boston scientific lead were then cut and removed from the patient.The physician was unable to determine which device was causing the high impedances.
 
Event Description
It was reported that the patient experienced high impedances and underwent a procedure to confirm if the pocket adapter or the non-boston scientific lead extension was the cause of high impedances.During the procedure, the physician attempted to use a torque wrench to remove the screw to disconnect the adapter from the non-boston scientific lead extension, however, the adapter screw was unable to be removed.The physician then attempted to use the correct wrench, various other wrenches, rubber pads and scissors but was still unable to remove the screw which had then been flattened and damaged.The physician then pulled the non-boston scientific lead extension from the adapter and separated the devices.The lead adapter and the non-boston scientific lead were then cut and removed from the patient.The physician was unable to determine which device was causing the high impedances.
 
Manufacturer Narrative
The returned b26 pocket adapter was analyzed, however, it cannot be confirmed that the pocket adapter was the cause of the impedance abnormality.It was suspected there was damage to the device which occurred during the original implant procedure.In addition, there was damage to the device during the attempt to remove the non-boston scientific lead extension from the b26 pocket adapter kit.The welds of the crimp sleeve to contact block c and d were broken.Visual inspection revealed that the silicon cover was damaged and torn away to the set-screw to contact d.The set-screw to contact d was unable to rotate as the hex socket was severely damaged.The damage incurred at both procedures does not allow for electrical measurements.Therefore, the cause of high impedances is unable to be determined.
 
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Brand Name
VERCISE
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
OSYPKA AG
earl-h.-wood-str.1
rheinfelden herten 79618
GM  79618
MDR Report Key10791362
MDR Text Key214751132
Report Number3006630150-2020-05372
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 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/31/2020
Device Model NumberDB-9418-15
Device Catalogue NumberDB-9418-15
Device Lot NumberP31135205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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