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

Model Number DB-9218-15

Device Problem Defective Device (2588)

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

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

Product family: dbs-adapters, upn: m365db9218150, model: db-9218-15, serial: unknown , batch: unknown.

Event Description

It was reported that the patient underwent a revision procedure to replace the ipg.During the procedure, the ipg exhibited high impedances on both sides of contacts 1 and 2 of the existing m8 adapters.The physician tried to remove both m8 adapters to clean them and insert them again.However, the device still exhibited high impedances and the physician was unable to pull out both of the adapters of the ipg.The physician removed the ipg and two m8 adapters.The physician replaced the devices with a new ipg and new m8 adapters.The procedure was successful.

Manufacturer Narrative

Investigation summary: with the available information, boston scientific concludes that the reported observations associated with high impedances exhibited on the m8 adapters was caused by unintended use error when the physician was unable to remove the m8 adapters from the ipg.Additionally, laboratory analysis identified that contacts #7 and #8 were crushed by the setscrew.Device technical analysis.The two returned adapters db-9218-15 lot: unknown were analyzed and revealed that the adapters were not fully inserted into the ports, therefore, impedance measurement will occur due to the misalignment of the lead and ipg contacts.The lead adapters remained in ports c/d and contacts #7 and #8 were crushed by the setscrew.The deformed contact resulted in the inability to remove the proximal arrays from the ipg header.

Event Description

It was reported that the patient underwent a revision procedure to replace the ipg.During the procedure, the ipg exhibited high impedances on both sides of contacts 1 and 2 of the existing m8 adapters.The physician tried to remove both m8 adapters to clean them and insert them again.However, the device still exhibited high impedances and the physician was unable to pull out both of the adapters of the ipg.The physician removed the ipg and two m8 adapters and replaced them with a new ipg and new m8 adapters and the procedure was successful.

• 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; cashel road; clonmel PR 00646 -260; EI 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12530005
• MDR Text Key: 273328140
• Report Number: 3006630150-2021-05374
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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