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 Blood Loss (2597); No Code Available (3191)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device components involved: product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), batch: 7075345.Product family: dbs-ipg-r-mri, upn: (b)(4), model: db-1200-s, serial: (b)(4), batch: 740793.

Event Description

It was reported that during a deep brain stimulator dbs implant procedure, following tunneling, the patient was bleeding excessively from a site near the ipg pocket incision.Pressure was applied on and off for over an hour but the bleeding continued.A thoracic surgeon was brought in and assessed that the extension may have penetrated the jugular vein which would of caused the excessive bleeding.The extensions were removed and tunneled again at the site more distal from the neck.The bleeding reduced.Following suturing and the application of bandages, an increase of swelling was noticed around the ipg pocket site and up near the clavicle.Pressure bandages were applied to keep weight on the site of the bleeding.The patient was admitted overnight to monitor the swelling.The swelling has since dissipated and the patients was noted to be fully recovered.

• Brand Name: NA
• 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; RQ 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11050913
• MDR Text Key: 223057858
• Report Number: 3006630150-2020-06307
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2020

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 Expiration Date: 03/04/2022
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7075373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR