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

Model Number 3772

Device Problems Failure to Charge (1085); Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Date of event and implant date is estimated.The results/method and conclusion codes along with investigation results will be provided on the final report.

Event Description

It was reported that the implantable pulse generator was unable to be charged resulting in the patient having a loss of effective therapy.Patient was charging the device as recommended prior to the device charging failure.The device was explanted, and a new device was implanted.There were no complications during the procedure.Patient was stable.

Manufacturer Narrative

The reported event of no communication /ipg inoperable was confirmed.At receipt, the ipg would not communicate with lab utilities due to a depleted battery.The battery was recovered and the ipg communicated, charged, but did not pass autotest due to two broken feed through wires.The broken feed through wire damage is consistent with damage that was sustained during the explant process.Ppe was unable to determine the root cause of reported event.

Manufacturer Narrative

The reported event of no communication /ipg inoperable was confirmed.At receipt, the ipg would not communicate with lab utilities due to a depleted battery.The battery was recovered and the ipg communicated and charged.Ppe was unable to determine the root cause of reported event.Corrected data: h6: investigations findings code 3252 - fracture problem has been removed from this report and was added in error.Investigation conclusions code 22 - known inherent risk of device has been removed from this report and was added in error.H10: manufacturer narrative has been corrected.

• Brand Name: PRODIGY MRI IPG, 16CH, RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10687397
• MDR Text Key: 211632033
• Report Number: 1627487-2020-32612
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• UDI-Public: 05415067017093
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: 5284475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other