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

Model Number 3660

Device Problem Low impedance (2285)

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

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.

Event Description

Related mfr reports: 3006705815-2021-02534 and 3006705815-2021-02535.It was reported the patient's scs system was exhibiting low impedance on multiple lead contacts.Reportedly, the patient controller displayed error message "mri is not advised, there may be a problem with the implanted leads" when attempting to set the scs system into mri mode.Surgical intervention may be taken to address the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for evaluation.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related mfr reports: 3006705815-2021-02534 and 3006705815-2021-02535.

• 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: 11860412
• MDR Text Key: 251840881
• Report Number: 3006705815-2021-02536
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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: 07/15/2020
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000062047
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3186, SCS LEAD; MODEL 3186, SCS LEAD
• Patient Outcome(s): Other