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

Model Number NM-3138-55

Device Problems Fracture (1260); High impedance (1291)

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

Event Date 03/23/2024

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-ipg-pc.Upn: m365db14160.Model: db-1416.Serial: (b)(6).Batch: 219682.Product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: (b)(6).

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure to explant and replace a competitors implantable pulse generator (ipg) with a boston scientific ipg.During the procedure, it was difficult for the physician to enter the lead extensions on both sides of the ipg ports, which caused the extension cable to break.The lead extensions were explanted and replaced.The ends of the lead extensions were cleaned with a wet gauze and dried before being inserted into the ports of the ipg.The patient was doing well postoperatively.

Manufacturer Narrative

Correction to the initial mdr in block(s) #s: a1, b3, and e1.

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure to explant and replace a competitors implantable pulse generator (ipg) with a boston scientific ipg.During the procedure, it was difficult for the physician to enter the lead extensions on both sides of the ipg ports, which caused the extension cable to break.The lead extensions were explanted and replaced.The ends of the lead extensions were cleaned with a wet gauze and dried before being inserted into the ports of the ipg.The patient was doing well postoperatively.

• 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: 19140873
• MDR Text Key: 340928922
• Report Number: 3006630150-2024-02459
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 05/24/2024

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: Health Professional
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7118175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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 Sex: Female