MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6662

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Twiddlers Syndrome (4563)

Event Date 04/07/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2022-02454, 1627487-2022-02455.It was reported that the patient experienced loss of therapy from one side.During following up with the patient on (b)(6) 2022, diagnostics revealed that there were low impedances.Reprogramming was unable to restore therapy.In turn, surgical intervention took place on (b)(6) 2022.During the procedure it was noted that the extensions were heavily intertwined and one of the extensions was broken.Reportedly, the patient rotated the ipg subcutaneously.As such, the extensions were explanted and replaced and the ipg was repositioned to its correct orientation addressing the issue.Reportedly, therapy was restored post operatively.

Manufacturer Narrative

Reporter phone number: (b)(6).Date of event is estimated.

• Brand Name: INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 14239051
• MDR Text Key: 290306067
• Report Number: 1627487-2022-02456
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 7600961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 05/24/2022
• Date Device Manufactured: 07/28/2020
• 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
• Treatment: DBS LEAD (X2)
• Patient Outcome(s): Other