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

Model Number NM-3138-55

Device Problems Use of Device Problem (1670); Low impedance (2285)

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

Event Date 07/01/2023

Event Type  Injury  

Event Description

It was reported that during the procedure to implant a second deep brain stimulation (dbs) lead to address worsening parkinsons symptoms the physician cut the waiting lead extension.Plasma blade and bipolar were used in relatively close proximity of the cut extension, which was warned against.When the impedance measurements were checked on the newly implanted lead connected to the waiting extension, it showed an impedance of 0 and a potential short on contact 6.The physician was advised post procedure that the patient was off label for magnetic resonance imaging (mri) and also due to the impedance findings the battery was likely damaged.The patient underwent a revision procedure where the implantable pulse generator (ipg) and damaged lead extension were replaced.The patient was doing well post-operatively.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-ipg-r-mri, upn: m365db12160, model: db-1216, serial: (b)(6), batch: (b)(6).

Manufacturer Narrative

The returned dbs lead extension nm-3138-55 serial number (b)(6) was analyzed, passed all tests performed, and exhibited normal device characteristics.The dbs lead extension nm-3138-55 serial number (b)(6) was not returned to bsc, as such analysis could not be performed in our laboratory.Additional suspect medical device component involved in the event: product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(6); batch: 7097845.

Event Description

It was reported that during the procedure to implant a second deep brain stimulation (dbs) lead to address worsening parkinsons symptoms the physician cut the waiting lead extension.Plasma blade and bipolar were used in relatively close proximity of the cut extension, which was warned against.When the impedance measurements were checked on the newly implanted lead connected to the waiting extension, it showed an impedance of 0 and a potential short on contact 6.The physician was advised post procedure that the patient was off label for magnetic resonance imaging (mri) and also due to the impedance findings the battery was likely damaged.The patient underwent a revision procedure where the implantable pulse generator (ipg) and damaged lead extension were replaced.The patient was doing well post-operatively.

• 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: 17465806
• MDR Text Key: 320473681
• Report Number: 3006630150-2023-04559
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• 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: 10/04/2023

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: 04/07/2024
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7097843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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: 72 YR
• Patient Sex: Female