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 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Further information requested, but not yet received.

Event Description

It was reported that the patient received a low battery warning.It is unknown if this occurred prematurely.As a result, surgical intervention may be undertaken in the future.

Manufacturer Narrative

Correction: additional information indicates the device meets or exceeds at least 75% of its expected longevity.This device is no longer considered to be reportable.

Event Description

Additional information indicates that the device meets or exceeds at least 75% of its expected longevity.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18682833
• MDR Text Key: 335068843
• Report Number: 3006705815-2024-00882
• Device Sequence Number: 1
• Product Code: LGW
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: 3660
• Device Lot Number: A000103400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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: Male
• Patient Weight: 79 KG