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

Model Number NM-3138-55

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Irritation (1941); Undesired Nerve Stimulation (1980); No Code Available (3191)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: db-1200, serial/lot: (b)(4), description: gevia dbs mri ipg sterile kit.Model: db-2202-45, serial/lot: (b)(4), description: dbs directional lead sterile kit 45cm.Model: db-2202-45, serial/lot: (b)(4), description: dbs directional lead sterile kit 45cm.Model: db-4600c, serial/lot: (b)(4), description: suretek burr hole cover kit.Model: nm-3138-55, serial/lot: (b)(4), description: 55cm 8 contact extension.

Event Description

A report was received that the patient experienced an infection after a revision procedure on (b)(6) 2019.The physician stated that the infection seemed to be due to the extension lead being exposed outside of the body.When the stimulation was turned on, the patient also experienced irritation on the extension connection part of the upper side.In addition, it was noted that the extension was cut midway during the procedure.

Event Description

A report was received that the patient experienced an infection after a revision procedure on (b)(6) 2019.The physician stated that the infection seemed to be due to the extension lead being exposed outside of the body.When the stimulation was turned on, the patient also experienced irritation on the extension connection part of the upper side.In addition, it was noted that the extension was cut midway during the procedure.

Manufacturer Narrative

Analysis of contact extension nm-3138-55 (serial number: (b)(4)) revealed that the as reported observations with testing of the product return were unable to be confirmed.However, visual inspection revealed that the lead body was cleanly cut.The proximal end portion of the lead extension was not returned.The cut damage is a result of a typical explant procedure and it is not considered a failure.A review of the manufacturing documentation for the ipg db-1200 (serial number: (b)(4)) revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the manufacturing documentation for the two leads db-2202-45 (serial numbers: (b)(4)) revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the manufacturing documentation for the suretek burr hole cover db-4600c (batch/lot number: 22606112) revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the manufacturing documentation for the contact extension nm-3138-55 (serial number: (b)(4)) revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9073947
• MDR Text Key: 158738382
• Report Number: 3006630150-2019-05078
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2021
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7040360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR