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

Model Number 3660

Device Problems Battery Problem (2885); No Apparent Adverse Event (3189)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  Injury  

Event Description

It was reported that the patient ipg was depleted, and it is unknown if the device depleted prematurely.The patient is not receiving therapy and will likely require surgical intervention to address the issue.

Manufacturer Narrative

Date of event estimated.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.

Event Description

Additional information was received that the device meets or exceeds 75% expected longevity and there were no known allegations of deficiencies against the device.Additional information was also received stating that surgical intervention took place where the ipg was explanted and replaced to address the issue.Effective stimulation was restored.

Manufacturer Narrative

Date of event estimated.Correction - section d: device information corrected.Correction: upon review, the issue should not have been submitted as a medical device report (mdr) as the device had met or exceeded 75% expected longevity.There is no alleged stated deficiency or malfunction of the device.This device is no longer considered reportable.

• 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): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18728390
• MDR Text Key: 335715283
• Report Number: 1627487-2024-06981
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: 3660
• Device Lot Number: A000082949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Sex: Male