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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the elective replacement indicator (eri) message displayed for the ipg.It is unknown if the ipg depleted prematurely.In turn, surgical intervention may be pending to address the issue.

Manufacturer Narrative

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

Event Description

Additional information received indicated 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15307940
• MDR Text Key: 298769823
• Report Number: 3006705815-2022-16301
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000102318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• 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
• Treatment: SCS LEAD X2
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 77 KG