MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3662

Device Problems Electromagnetic Interference (1194); Intermittent Energy Output (4025)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/24/2020

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

It was reported the patient complaint the scs ipg was turning off and on without prompting.Analysis of the system logs confirmed the system's therapy had turned off by interacting with a sufficient magnetic field a total of five times.To address the issue the patient's scs ipg was successfully replaced with a new one.

Manufacturer Narrative

The reported issue of turning on/off intermittently was confirmed and found to be the result of multiple interactions with a magnet or sufficient magnetic field.The ipg passed all tests on the auto-test equipment (ate).No issues were noted with magnet during ate testing process.

Manufacturer Narrative

Corrected data: d7 - date of explant.

• Brand Name: PROCLAIM 7 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: 10525434
• MDR Text Key: 206713634
• Report Number: 1627487-2020-31367
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• 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,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2018
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 5474524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 95