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

Model Number 6662

Device Problem Wireless Communication Problem (3283)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Event date is unknown.During processing of this complaint, attempts were made to obtain complete patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient¿s ipg could not be connected to the patient controller after not being placed into surgery mode during an unrelated surgery.Intervention will be considered at a later date.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information received indicates that the patient underwent ipg replacement surgical intervention.Therapy was restored post-operatively.

• Brand Name: INFINITY 7 IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10896890
• MDR Text Key: 218685826
• Report Number: 1627487-2020-48088
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2020
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 6525783
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 100