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

Model Number DB-2201-45-DC

Device Problems Off-Label Use (1494); Unexpected Therapeutic Results (1631)

Patient Problem Pain (1994)

Event Date 01/14/2024

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7114051; product family: dbs-extension, upn: m365db312855b0, model: db-3128-55b, serial: (b)(6), batch: 5002044; product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, batch: 32076167.

Event Description

It was reported that the patient was implanted with two deep brain stimulation (dbs) leads and an extension.The physician made the decision to externalize the extension and attempt programming with an external trial stimulator (ets) to see if this would address the patient's facial pain.Postoperative programming was not able to relieve the patient's pain and the patient then underwent a procedure to remove the implanted devices.Physical analysis could not be conducted in our laboratory, as the devices were retained by the facility.

• 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; 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: 18567864
• MDR Text Key: 333536907
• Report Number: 3006630150-2024-00209
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• UDI-Public: 08714729836544
• 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
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DB-2201-45-DC
• Device Catalogue Number: DB-2201-45-DC
• Device Lot Number: 7074251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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 Age: 65 YR
• Patient Sex: Male