MAUDE Adverse Event Report: ABBOTT MEDICAL ST. JUDE MEDICAL INFINITY¿; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 6173

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 02/11/2022

Event Type  malfunction  

Event Description

Elderly female with history of essential tremors had one of the first deep brain stimulation (dbs) systems placed about 20 years ago.The leads broke, and we replaced leads & generator 7 years ago.Her left-sided control has not been good even with the change.She has a defibrillator and we have not been able to get an mri for targeting.There are impedance issues, and she is not getting good therapy and wished to have the system replaced again but this time with directional leads.From operative report: we tried to lock down the guardian device but it failed.We had to remove the electrode and the guardian.We put a new guardian on and passed the electrode and confirmed position with xray.The electrode was locked down with the guardian device while confirming fluoroscopically that there was not displacement of the electrode as the locks were engaged.The superficial end of the electrode was covered with a connector and bootie and was passed under the scalp to the right.Implant ultimately was st.Jude medical 6173 x 2 l: 18989133, r: 18829555.Guardian cranial burr hole cover system 6101 both ln: 8124270.Patient transferred to icu in stable condition.

• Brand Name: ST. JUDE MEDICAL INFINITY¿
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston road; plano TX 75024
• MDR Report Key: 13848024
• MDR Text Key: 287619792
• Report Number: 13848024
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6173
• Device Catalogue Number: 6173
• Device Lot Number: 8124270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Race: White