MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problem Battery Problem (2885)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The device has the appropriate level of battery voltage to provide therapy.

Manufacturer Narrative

A system displaying warning message ¿replace generator soon¿ warning message was reported to abbott.As a result, the patient¿s ipg was explanted and replaced.Therapy was restored.The results of the investigation are inconclusive since the implant was not returned for analysis.Based on the information received, the reported event is consistent with the implant reaching end of service.

Event Description

Additional information indicated that a surgical intervention occurred wherein the ipg was explanted and replaced to address the issue.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 12523805
• MDR Text Key: 273123986
• Report Number: 3006705815-2021-04708
• 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
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2021
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000084342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other