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

Model Number 3660

Device Problems Impedance Problem (2950); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain patient weight, and but it was not received.

Event Description

Related manufacturer report number: 3006705815-2021-03974, 3006705815-2021-03975.It was reported the patient was unable to place their scs system into mri mode, prior to an mri procedure.Diagnostics confirmed low impedance on patient's leads.Surgery may occur later to address the issue.

Manufacturer Narrative

Correction - h6: added health code 4629 - device revision or replacement that was inadvertently left off initial report.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 received indicate the patient underwent a surgical procedure for a lead revision on (b)(6) 2021, wherein the leads were explanted and replaced due to low impedances showing at zero ohms.During the same surgery the ipg was electively explanted and replaced.Therapy re-established post-operatively.

Manufacturer Narrative

Correction - h6: medical device code did not refresh for final codes to submit properly.Codes have been updated.

• 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
• MDR Report Key: 12388827
• MDR Text Key: 268887839
• Report Number: 3006705815-2021-03976
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000085694
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD (X2)
• Patient Outcome(s): Other
• Patient Age: 40 YR