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

Model Number 3660

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patient's ipg became unable to communicate with external devices.Troubleshooting was unable to be resolve the issue.As a result, surgical intervention was undertaken on (b)(6) 2022 wherein the ipg was explanted and replaced to address the issue.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.The reported observation of ¿no ipg communication¿ was confirmed.The analysis results concluded the inability to establish communication between the programmer and the implantable pulse generator (ipg) was due to the device entering the service application state on approximately (b)(6)2022.The root cause of the device entering the service application state was not ascertained.The battery voltage at the time of service application entry was 3.008v, which is considered a good voltage.Stimulation was active at the time-of-service application.The ipg's inability to communicate is consistent with the use of electrocautery although the patient reported having no unrelated procedures.Per the clinicians manual arten600266417 warnings - electrosurgery.To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems.Before using an electrosurgery device, place the device in surgery mode using the patient controller app or clinician programmer app.Confirm the neurostimulation system is functioning correctly after the procedure.Under warnings - there is sufficient documentation concerning the use of use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system, and medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).

• 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: 15222805
• MDR Text Key: 297857855
• Report Number: 3006705815-2022-15877
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000100324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2020
• 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 ANCHOR (X2); SCS LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Female