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

Model Number DB-4600C

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved: product family: dbs-linear lead: upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 5082417.Product family: dbs-linear lead : upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 5113686.Product family: dbs-linear lead: upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 5070044.Product family: dbs-lead fixation: upn: (b)(4), model: db-4600c, batch: 23403354.Product family: dbs-lead fixation: upn: (b)(4), model: db-4600c, batch: 23198103.Product family: dbs-lead fixation: upn: (b)(4), model: db-4605c, batch: 23021393.A review of the manufacturing documentation for the burr hole cover revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that during the implant procedure, the burr hole locking feature may have failed as physician found the lead had migrated.The physician replaced the lead and used a new burr hole cover.Later that same day, the physician discovered both leads had retracted, so patient underwent a revision procedure wherein the leads were explanted.Patient was doing well post operatively.

• Brand Name: SURETEK
• 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): CARDIAC PACEMAKERS, INC.; 4100 hamline ave n; st paul MN 55112
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 8571485
• MDR Text Key: 143793398
• Report Number: 3006630150-2019-01984
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: 08714729820802
• 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: 05/01/2019

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: 01/25/2021
• Device Model Number: DB-4600C
• Device Catalogue Number: DB-4600C
• Device Lot Number: 23198103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2019
• 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: 58 YR