MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 7 ELITE; SCS IPG

Model Number 3662

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

Event Description

It was reported the patient was unable to establish a connection between the ipg and the patient controller (pc).A company representative met with the patient and confirmed the issue by also using the clinician programmer (cp).The cp displayed an error message: "ipg repair attempted, the programmer will reconnect when ipg is ready." the representative attempted multiple times to connect to the ipg, but to no avail.The patient stated they underwent a surgical procedure and did not place the device into surgery mode prior to surgery.In turn, the patient may undergo surgical intervention as the next course of action.

Event Description

It was reported that the patient underwent surgical intervention wherein the scs ipg was explanted and replaced to address the issue.

Manufacturer Narrative

A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.The results of the investigation are inconclusive since the device was not returned for analysis.Actions have been taken to prevent reoccurrence.

Manufacturer Narrative

The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery was used.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.The results of the investigation are inconclusive since the device was not returned for analysis.Actions have been taken to prevent reoccurrence.

• Brand Name: PROCLAIM 7 ELITE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8951895
• MDR Text Key: 156263301
• Report Number: 3006705815-2019-03356
• Device Sequence Number: 1
• Product Code: LGW
• 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,consum
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: 3662
• Device Lot Number: A000067943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 159