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

Model Number DB-3128-55

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Failure to Disconnect (2541); Impedance Problem (2950)

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

Event Date 03/09/2023

Event Type  malfunction  

Event Description

It was reported that during the first stage of the deep brain stimulation (dbs) implant procedure, impedances were within a normal range on the left lead, however the left lead had open contacts during the second stage of the implant procedure later that day.The physician had difficulty removing the extension from the lead therefore, the proximal end of the left lead was cut and removed, the lead extension was also removed, and the procedure was aborted.There were no patient complications postoperatively.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(4).Batch: (b)(4).

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7101405.Device analysis performed on the returned lead extension revealed that it was cleanly cut 2 cm from the connector.Electrical testing could not be performed due to the cut lead extension body.Therefore, with all the available information, engineers concluded that the cause of the reported high impedance reading was unable to be determined based on the lead extension analysis.Device analysis performed on the returned lead revealed that it was cleanly cut with only the proximal end of the lead being returned.A visual inspection revealed that the eighth contact on the lead appeared to be crushed by the associated lead extension setscrew.Engineers determined that this damage resulted in the reported event of difficulty removing the lead from the lead extension.Additionally, it was concluded that the lead became fractured likely due to excessive force when the lead proximal array was extracted.A review of the instructions for use (ifu) states to avoid sharply bending the lead or lead extension, and avoid damaging the lead with excessive force during surgery.

Event Description

It was reported that during the first stage of the deep brain stimulation (dbs) implant procedure, impedances were within a normal range on the left lead, however the left lead had open contacts during the second stage of the implant procedure later that day.The physician had difficulty removing the extension from the lead therefore, the proximal end of the left lead was cut and removed, the lead extension was also removed, and the procedure was aborted.There were no patient complications postoperatively.

• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16678580
• MDR Text Key: 312712013
• Report Number: 3006630150-2023-01786
• 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: 06/01/2023

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: Health Professional
• Device Expiration Date: 11/02/2022
• Device Model Number: DB-3128-55
• Device Catalogue Number: DB-3128-55
• Device Lot Number: 5000523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2020
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White