MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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 received the "elective replacement indicator" message on their ipg.It is unknown whether this message triggered earlier than intended.The device is still providing stimulation.Surgical intervention may be undertaken at a later date to replace the ipg.

Manufacturer Narrative

Patient weight added to the record.

Event Description

Additional information received stated that the patient's ipg was explanted and replaced on (b)(6) 2020.Post-operatively, stimulation therapy was restored.

Manufacturer Narrative

H6 device code updated to 3189 based on new information.An elective replacement indicator message was reported to abbott.Based on the information received, the cause of the reported incident is consistent with the battery nearing end of life.

Event Description

Additional information received through further analysis of the generator logs revealed that the eri message triggered normally and is consistent with the ipg nearing normal end of life.

• Brand Name: PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9877931
• MDR Text Key: 184964712
• Report Number: 1627487-2020-03257
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 5855343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 113