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

Model Number DB-1140-S

Device Problem Defective Device (2588)

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

Event Date 07/15/2022

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 298072994
• Report Number: 3006630150-2022-04014
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2019
• 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 Age: 62 YR
• Patient Sex: Female