MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number DB-1200

Device Problems Unexpected Therapeutic Results (1631); Device Displays Incorrect Message (2591); Charging Problem (2892); Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a wound cleanse with antiseptics at the site of the deep brain stimulator (dbs) burr hole cover behind the right ear, related mdr number 3006630150-2021-05824.An hour after the cleansing procedure, the dbs stimulation suddenly stopped delivering therapy, charging was unsuccessful and communication could not be established.The patient underwent a replacement of the implantable pulse generator (ipg) and was doing fine post-operatively.

Event Description

It was reported that the patient underwent a wound cleanse with antiseptics at the site of the deep brain stimulator (dbs) burr hole cover behind the right ear, see related mdr number 3006630150-2021-05824.An hour after the cleansing procedure, the dbs stimulation suddenly stopped delivering therapy, charging was unsuccessful and communication could not be established.The patient underwent a replacement of the implantable pulse generator (ipg) and was doing fine post-operatively.

Manufacturer Narrative

Device analysis of returned ipg db-1200 (740454) revealed that device was undetectable nor charged.The device was cut open, and the battery measured 1.54 volts.The patient's data obtained by using a power supply showed that the battery plunged.An internal electrical test revealed u2 asic (application-specific integrated circuit) damage with excessive quiescent current leak and high thermal spot on it.It could not be confirmed if electrocautery was used during the wound cleanse procedure.However, based on the signature of the damage, it appeared that the device was exposed to high-voltage transients or high rf (radio frequency) energy which can cause this type of damage.

• Brand Name: VERCISE GEVIA
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12647991
• MDR Text Key: 276893073
• Report Number: 3006630150-2021-05828
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2021
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 740454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention