MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3662

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/31/2022

Event Type  Injury  

Event Description

It was reported the patient underwent a non-related surgical procedure wherein the ipg was not placed into surgery mode prior to the procedure.As a result, the patient's ipg was unable to communicate with external devices and the patient lost therapy.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.Surgical intervention may occur at a later date to address the issue.

Manufacturer Narrative

Date of event is estimated.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

Manufacturer Narrative

A4 - patient weight is estimated.An inoperable implant was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used.The implant was not returned for analysis.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Based on the information received, the cause of the reported incident is consistent with user error.

Event Description

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

• Brand Name: PROCLAIM¿ 7 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: 15172379
• MDR Text Key: 297310107
• Report Number: 3006705815-2022-15927
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031426
• UDI-Public: 05415067031426
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: A000101966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-060217-001-C
• Patient Sequence Number: 1
• Treatment: SCS LEAD
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 91 KG