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

Model Number	DB-1140-S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an elective procedure to replace the deep brain stimulation (dbs) implantable pulse generator (ipg), a portion of the ipg port plug was found in the ipg pocket site.The port plug was removed and the patient was doing well post-operatively.
Additional Manufacturer Narrative
The returned portion of the port plug, without the head, was removed from port d of the ipg.Engineers determined that the head was broken off when it was forcefully pulled during the explant procedure, thus unintended use error caused or contributed to the event.
Event or Problem Description
It was reported that during an elective procedure to replace the deep brain stimulation (dbs) implantable pulse generator (ipg) a portion of the ipg port plug was found in the ipg pocket site.The port plug was removed, and the patient was doing well post-operatively.Additional information was received that the head portion of the port plug was discarded by the medical facility.

• Brand Name: VERCISE PC
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15219779
• Report Number: 3006630150-2022-04014
• Device Sequence Number: 5887499
• Product Code: NHL
• UDI-Device Identifier: 08714729984467
• UDI-Public: 08714729984467
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/12/2021
• Device Model Number: DB-1140-S
• Device Catalogue Number: DB-1140-S
• Device Lot Number: 631492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female