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

Model Number DB-1110C

Device Problems Unexpected Therapeutic Results (1631); Charging Problem (2892); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 03/12/2019

Event Type  Injury  

Event Description

A report was received that a patient's ipg shuts off on it's own.The patient would undergo reprogramming of the ipg and the program would work normally.When the next program would be activated, the ipg would shut off.The patient also complained that the ipg had to be charged every two days.The patient's ipg was explanted and replaced.The patient is satisfied following the surgery.

Manufacturer Narrative

The returned ipg was analyzed and passed all required tests and exhibited normal device characteristics.

Event Description

A report was received that a patient's ipg shuts off on it's own.The patient would undergo reprogramming of the ipg and the program would work normally.When the next program would be activated, the ipg would shut off.The patient also complained that the ipg had to be charged every two days.The patient's ipg was explanted and replaced.The patient is satisfied following the surgery.

• 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
• MDR Report Key: 8565782
• MDR Text Key: 143582264
• Report Number: 3006630150-2019-01947
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820758
• UDI-Public: 08714729820758
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2020
• Device Model Number: DB-1110C
• Device Catalogue Number: DB-1110C
• Device Lot Number: 21606578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR