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

Model Number 3662

Device Problem Device Inoperable (1663)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

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 the patient underwent an unrelated surgical procedure on (b)(6) 2018.The patient was unable to connect the ipg with any other devices postoperatively, and the clinical programmer displayed the error message, ¿a problem was found with the generator that could not be repaired.¿ troubleshooting attempts have been unsuccessful, and the ipg has been deemed inoperable.As a result, the patient may be awaiting surgical intervention to explant and replace the ipg.

Manufacturer Narrative

The capa was initiated on (b)(6) 2016 to address the issue of the proclaim ipg entering service application.Investigation is complete and being monitored by the manufacturer.

Event Description

Follow up information identified the physician explanted and replaced the patient¿s ipg.Additionally, it was learned electrocautery was utilized during the surgery on (b)(6) 2018.

• 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
• MDR Report Key: 7548417
• MDR Text Key: 109362452
• Report Number: 1627487-2018-05244
• Device Sequence Number: 1
• Product Code: LGW
• 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,consum
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2019
• Device Model Number: 3662
• Device Lot Number: 6079331
• Other Device ID Number: 05415067020222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-060217-001-C
• Patient Sequence Number: 1
• Treatment: MODEL 2311 (X2), SCS ADAPTER
• Patient Outcome(s): Other
• Patient Age: 59 YR