MAUDE Adverse Event Report: ABBOTT MEDICAL PRODIGY MRI IPG, 16CH, RECHARGEABLE; SCS IPG

Model Number 3772

Device Problems Temperature Problem (3022); Wireless Communication Problem (3283)

Patient Problems Burning Sensation (2146); Inadequate Pain Relief (2388)

Event Date 02/21/2024

Event Type  Injury  

Event Description

It was reported that the ipg failed to establish communication with external devices.The ipg was deemed inoperable, and patient lost therapy.Surgical intervention may take place to address the issue.

Manufacturer Narrative

B3-date of event is estimated.

Manufacturer Narrative

Corrected data: b5: describe event or problem.H6: adverse event problem (refer to coding manual).

Event Description

It was reported that patient experienced heating at the ipg pocket site.Surgical intervention may take place to address the issue.

• Brand Name: PRODIGY MRI IPG, 16CH, RECHARGEABLE
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18918445
• MDR Text Key: 337843135
• Report Number: 1627487-2024-07577
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• UDI-Public: 05415067017093
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P010032
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2018
• Device Model Number: 3772
• Device Lot Number: 5502409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• 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
• Patient Outcome(s): Other