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

Model Number 3662

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2018

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 manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The device has the appropriate level of battery voltage to provide therapy.However, device replacement may take place later.

Manufacturer Narrative

True end of life not eri.

Event Description

Follow up information determined though the device was not returned the event details indicated the voltage level of the device is within specifications to trigger the eri indicator.Based on the information received the cause of the reported incident is consistent with the battery nearing true end of life.

Manufacturer Narrative

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

The patient underwent an ipg replacement on (b)(6) 2019.Effective therapy was restored post op.

• Brand Name: PROCLAIM 7 ELITE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: tanja hoffman ; 6901 preston road; plano, TX 75024 ; 9723098520
• MDR Report Key: 7748360
• MDR Text Key: 115969641
• Report Number: 1627487-2018-07210
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Model Number: 3662
• Device Lot Number: 5899624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/09/12/2017/001-C
• Patient Sequence Number: 1
• Treatment: MODEL 1192 (2), SCS ANCHOR; MODEL 3186 (2), SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 73