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

Model Number 3662

Device Problems Premature Elective Replacement Indicator (1483); Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the wireless software update was performed clearing the elective replacement indicator (eri) message thereby issue resolved.The device is providing therapy.

Manufacturer Narrative

An accurate longevity estimation calculation was unable to be performed as the programming parameters that were provided did not appear to be the complete settings used for the service life of the device.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.

Manufacturer Narrative

H1 has been updated from malfunction to serious injury.

Event Description

Additional information received indicated patient underwent surgical intervention wherein the ipg was explanted and replaced.Reportedly effective therapy was resolved.

Manufacturer Narrative

"a longevity estimation calculation was unable to be performed as the programming parameters that were provided did not appear to contain complete settings used for the service life of the device."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.

• 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: 10347855
• MDR Text Key: 201389226
• Report Number: 1627487-2020-23006
• 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,consum
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2019
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 6164874
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 01/28/2021; 05/26/2021
• Supplement Dates FDA Received: 12/09/2020; 02/17/2021; 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/09/12/2017/001-C
• Patient Sequence Number: 1
• Patient Weight: 107