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

Model Number DB-2203-45C

Device Problems Fracture (1260); High impedance (1291); Low impedance (2285); Material Twisted/Bent (2981)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It was reported that directly after the deep brain stimulator lead was implanted, impedances were measured directly on the lead using the or cable and external trial stimulator, and all impedances were good, and the skull was closed.Approximately one hour later the lead was connected to the lead extension, and very low impedances and very high impedances were observed.In addition, a little kink in the lead contact array that goes into the lead extension was noticed.It was also noted that the lead was broken or fractured.The hypothesis is that lead breakage happened somewhere in the process of demounting the frame and putting the lead under the skin, and that the lead breakage is with high probability caused by this kink.The fracture was not confirmed by x-ray but seen by the naked eye on the contact array was out of the body for connection with the lead extension.The patient underwent a lead replacement surgery was doing fine post-operatively.All impedance issues were resolved with replacement of the lead.

Manufacturer Narrative

Model db-2203-45c, serial (b)(6): visual inspection of the returned lead revealed that the lead was damaged on spacer next to the directional market and electrode e12 was missing.It was confirmed that electrode e12 was not left inside the patient.The lead failed the crosstalk test on multiple contacts.Visual inspection of the proximal end of the lead was bent-kinked between contacts e11 and e12.The cables are exposed at the fracture site.A review of the manufacturing documentation for the device revealed that no anomalies or deviations related to the event occurred during manufacturing.The directions for use states that the user should avoid damaging the lead with excessive force during surgery.Therefore, the probable cause selected is unintended use error caused or contributed to event.

Event Description

It was reported that directly after the deep brain stimulator lead was implanted, impedances were measured directly on the lead using the or cable and external trial stimulator, and all impedances were good, and the skull was closed.Approximately one hour later the lead was connected to the lead extension, and very low impedances and very high impedances were observed.In addition, a little kink in the lead contact array that goes into the lead extension was noticed.It was also noted that the lead was broken or fractured.The hypothesis is that lead breakage happened somewhere in the process of demounting the frame and putting the lead under the skin, and that the lead breakage is with high probability caused by this kink.The fracture was not confirmed by x-ray but seen by the naked eye on the contact array was out of the body for connection with the lead extension.The patient underwent a lead replacement surgery was was doing fine post-operatively.All impedance issues were resolved with replacement of the lead.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13973497
• MDR Text Key: 288388144
• Report Number: 3006630150-2022-01374
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/11/2023
• Device Model Number: DB-2203-45C
• Device Catalogue Number: DB-2203-45C
• Device Lot Number: 5000637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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
• Patient Sex: Male