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

Model Number DB-1140

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Fall (1848); Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 12/01/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced a fall unrelated to the device.The patient experienced trauma to the head, chest, and side of the ribs on the ipg left side.The patient was not receiving adequate pain relief.The physician suspected damage to the ipg.The patient underwent a revision procedure where the ipg was replaced.The patient was noted to be stable post-operatively.

Manufacturer Narrative

Device technical analysis: engineers inspected and analyzed this ipg upon receipt, the device passed all tests performed, and exhibited normal device characteristics.Investigation conclusion: based on all available information, engineers concluded that the reported event of the patient experiencing inadequate pain relief due to a non-device related fall could not be confirmed through laboratory analysis of the device, as the ipg passed all tests performed, and exhibited normal device characteristics.

Event Description

It was reported that the patient experienced a fall unrelated to the device.The patient experienced trauma to the head, chest, and side of the ribs on the ipg left side.The patient was not receiving adequate pain relief.The physician suspected damage to the ipg.The patient underwent a revision procedure where the ipg was replaced.The patient was noted to be stable post-operatively.

• Brand Name: VERCISE PC
• 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: 13725223
• MDR Text Key: 287001832
• Report Number: 3006630150-2022-00959
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2023
• Device Model Number: DB-1140
• Device Catalogue Number: DB-1140
• Device Lot Number: 633341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• 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