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

Model Number DB-9218-15

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-adapters, upn: m365db9218150, model: db-9218-15, serial: (b)(4), batch: 5180039.The dbs m8 adapters db-9218-15 (serial numbers (b)(4)) were analyzed, passed all tests performed, and exhibited normal device characteristics.The investigation concluded that the reported event was not confirmed through device analysis.Therefore, a probable cause cannot be determined as no problem has been detected.

Event Description

It was reported that the patient underwent a procedure to switch from a non-bsc implantable pulse generator (ipg) to a bsc ipg.During the implant procedure, m8 adaptors were implanted to connect the existing non-bsc leads to the new bsc ipg.An impedance check showed appropriate connectivity so the connection was secured and the patient was sutured.A second impedance check showed high impedances.The physician re-opened the sub clavicular pocket and replaced the m8 adaptors, however, the high impedances remained.The physician decided to keep the system implanted as they could program effective therapy using the normal impedance contacts.

• Brand Name: VERCISE
• 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: 10863155
• MDR Text Key: 216965169
• Report Number: 3006630150-2020-05652
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 5180037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2019
• 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: 77 YR
• Patient Weight: 104