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

Model Number 3660

Device Problems Premature Discharge of Battery (1057); Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.

Event Description

It was reported the patient felt her pain increase and attempted to turn up her scs system stimulation amplitude, but was unable.Reportedly, when she connected with the controller the message, "replace generator, the generator has reached its end of service" showed.A company representative met with the patient and confirmed the patient's scs ipg had reached its end of life.Surgical intervention would be necessary to replace the patient's scs ipg.

Event Description

Follow up information obtained identified the patient's implantable generator was successfully replaced, and stimulation therapy restored postoperatively.

Manufacturer Narrative

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

• 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: 10320635
• MDR Text Key: 200241327
• Report Number: 1627487-2020-23196
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2020
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 6553739
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 115