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); Charging Problem (2892); Wireless Communication Problem (3283)

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

Event Date 09/13/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: vercise gevia, upn: unk-t-internal_leads, model: unknown, serial: unknown, batch: unknown.

Event Description

It was reported that the patient experienced difficulty charging the ipg, implantable pulse generator, and was provided a new charging kit.It was indicated that following a lead revision procedure two clinician programmers and the patient's remote control were used and none were able to communicate with the ipg.It was suspected that the ipg was in hibernation, however the issue was not resolved with the new charging kit.Additionally, it was indicated that plasma blade diathermy was used for dissection of the soft tissues during the previous lead revision procedure.The patient underwent an ipg replacement procedure and regained therapy, the patient is doing well post operatively.The ipg is pending return to the manufacturer for analysis.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads; upn: m365db220130a0; model: db-2201-30a; serial: unknown; batch: unknown.Device technical analysis: the returned ipg was analyzed, the device was cut open, and the battery measured 1.569 volts.The device exhibited excessive quiescent current leakage (23.2 ma), low vh (high voltage) impedance (101 ohms), and a hot spot on u2 asic (application-specific integrated circuit) (30.3c).Labeling review: a labeling review was performed on the ipg instructions for use, ifu and there was no evidence that the device was used in a manner inconsistent with the labeled indications.However, diathermy: shortwave, microwave and/or therapeutic ultrasound diathermy should not be used on patients implanted with the boston scientific dbs system, or any of the system components.The stimulator, whether it is turned on or off, may be critically damaged by the use of diathermy.Investigation conclusion: based on all available information, engineers concluded that the reported event was confirmed.The u2 asic was damaged.Plasma usage is a known source of high voltage transient signals.This information suggests that the device was damaged by the plasma blade diathermy during the revision.The probable cause is unintended use error caused or contributed to the event.

Event Description

It was reported that the patient experienced difficulty charging the ipg, implantable pulse generator, and was provided a new charging kit.It was indicated that following a lead revision procedure two clinician programmers and the patient's remote control were used and none were able to communicate with the ipg.It was suspected that the ipg was in hibernation, however the issue was not resolved with the new charging kit.Additionally, it was indicated that plasma blade diathermy was used for dissection of the soft tissues during the previous lead revision procedure.The patient underwent an ipg replacement procedure and regained therapy, the patient is doing well post operatively.The ipg is pending return to the manufacturer for analysis.

• 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: 12611497
• MDR Text Key: 276124463
• Report Number: 3006630150-2021-05683
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2021
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 736959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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