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

Model Number 3660

Device Problems Unintended Power Up (1162); Temperature Problem (3022); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

Date of event¿ is estimated.During processing of this complaint, attempts were made to obtain complete event information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that ipg is turning on involuntarily.Surgery may occur to address the issue.The elective replacement indicator (eri) message appeared for the same ipg as documented in related manufacturer reference number 3006705815-2020-02261.

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 was received that patient experienced ineffective therapy, ipg was overheating, and that ipg became inoperable.

Event Description

Additional information received an ipg explant took place on an unknown date.Medwatch form #: mw5150477.

Manufacturer Narrative

The reported observation of ¿the ipg turning on involuntarily¿ was confirmed.The analysis results concluded the ipg turning on/off was due to the device being in the proximity of a magnetic field.This was concluded due to the sequence and frequency of occurrence noted in the therapy delivery log.It was also stated in the epiq event details that the patient worked in an area with strong magnetic fields.No anomalies were noted in the ipg logs concerning the magnet functionality.Based on the available information with no further programming history provided the device exceeded 97% of the estimated longevity based on program #2 and how it was utilized.No program impedances were provided, and the impedance logging option was not enabled at any time during the implant duration.It was noted during the initial query of the device using a clinician programmer no programs or lead types were available in the session report.Taking into consideration of how the device was programmed it is considered to have normal battery depletion at the time of explant the device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.The ate specifically tests the magnet function and the stimulation output tolerances.The reported observation was dated (b)(6) 2020.It appeared the device stimulation was last turned off on (b)(6) 2020.The device had declared ipg elective replacement (eri) on (b)(6)2020.The device was explanted on (b)(6) 2020.Based on the calculated timeline the device continued to operate and deplete the battery until (b)(6) 2023.

• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10204539
• MDR Text Key: 196790194
• Report Number: 3006705815-2020-02448
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• 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: Other,Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000064343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/28/2020
• Supplement Dates Manufacturer Received: 08/05/2020; 10/15/2020; 01/08/2024; 04/17/2024
• Supplement Dates FDA Received: 08/10/2020; 10/30/2020; 02/06/2024; 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 68 KG