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

Model Number DB-1110-C

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

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

Event Date 05/11/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced difficulty charging the implantable pulse generator ipg.Due to the patient having difficulty charging, the physician could not communicate with the ipg.The patient was admitted to the hospital and after tests, the level of the battery stayed the same.The patient underwent a procedure where the ipg was replaced.The patient was noted to have recovered post operatively.

Manufacturer Narrative

The returned ipg passed visual inspection and was able to be fully recharged.It passed all functional tests and sleep current was normal.However, an analysis of the data log revealed that the ipg-charger was not optimal and was stopping although the thermistor was not being triggered.

Event Description

It was reported that the patient experienced difficulty charging the implantable pulse generator ipg.Due to the patient having difficulty charging, the physician could not communicate with the ipg.The patient was admitted to the hospital and after tests, the level of the battery stayed the same.The patient underwent a procedure where the ipg was replaced.The patient was noted to have recovered post operatively.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17081815
• MDR Text Key: 316746018
• Report Number: 3006630150-2023-03229
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820758
• UDI-Public: 08714729820758
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/26/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2018
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 2000021071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2013
• 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