MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 6660

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

Patient Problem Twiddlers Syndrome (4563)

Event Date 10/03/2022

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown.

Event Description

Related manufacturer reference number: 1627487-2022-06035.It was reported that the patient experienced entanglement of the extension wires in the ipg pocket due to twiddling.As a result, the patient underwent a surgical procedure on (b)(6) 2022 during which the extension wires were corrected and the ipg was stitched into a mesh cover to prevent future complications.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS 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: 15736973
• MDR Text Key: 303097013
• Report Number: 1627487-2022-06034
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: 05415067020246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 6922154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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
• Treatment: DBS LEAD
• Patient Outcome(s): Other
• Patient Sex: Female