MAUDE Adverse Event Report: ABBOTT MEDICAL DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG); STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

We were informed on (b)(6) 2023 about revision surgery in which the physician wanted to replace the patient's abbott scientific deep brain stimulation (dbs) implantable pulse generator (ipg) with a (b)(6) ipg.During the implant procedure, there was a problem with the abbott lead extension wires and ipg.There was no issue with the (b)(6) lead adaptor or with any of the(b)(6) devices.Due to the problem with the abbott devices, the procedure had to be rescheduled to the following day.The surgery occurred at (b)(6) and the physician's name is dr.(b)(6).The devices are not devices manufactured by (b)(6).If you have questions or need additional information, please contact me at the phone number below.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG)
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18335879
• MDR Text Key: 330772416
• Report Number: MW5149294
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Patient Sequence Number: 1