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

Model Number 3670

Device Problem Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  Injury  

Event Description

It was reported that the patient's ipg was exhibiting signs low impedance that were preventing the patient's system from entering mri mode.The patient underwent surgical intervention on (b)(6) 2024.Wherein the patient's ipg was explanted, replaced, and therapy was restored.Following the surgery the patient's impedance issue reportedly resolved.

Manufacturer Narrative

Section b3: event date is estimated.

• Brand Name: PROCLAIM PLUS 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19082993
• MDR Text Key: 339896356
• Report Number: 3006705815-2024-02734
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067046383
• UDI-Public: (01)05415067046383(10)A000148951(17)251009
• 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
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3670
• Device Lot Number: A000148951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2023
• 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 (X1).
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 91 KG