MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with the investigation results will be provided in final report.

Event Description

Related manufacturer reference number: 3006705815-2020-02400.It was reported the patient experienced ineffective stimulation.Xrays revealed the lead had pulled out of the ipg port.Surgical intervention may be pending to address the issue.

Manufacturer Narrative

Date of explant is estimated.

Event Description

It was reported during follow up that the patient underwent surgical intervention the week of (b)(6) 2020 wherein the patients ipg and lead were explanted and replaced.

Manufacturer Narrative

The results of the investigation are inconclusive, and the root cause of the reported incident is unknown as the device was not returned for analysis.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10179729
• MDR Text Key: 195951976
• Report Number: 1627487-2020-22012
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

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: 11/19/2021
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 7282838
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 09/02/2020
• Supplement Dates FDA Received: 09/02/2020; 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD; SCS LEAD
• Patient Age: 39 YR
• Patient Weight: 78