MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE; SCS IPG

Model Number 3660

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.During processing of this complaint, attempts were made to obtain weight but not received.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 that the patient underwent an unrelated medical surgery.In turn, the ipg was unable to communicate and the ipg was deemed inoperable.Surgical intervention may be planned to address this issue.

Manufacturer Narrative

Corrected data: applicable fields corrected to reflect returned and analyzed device.

Event Description

Follow up identified that the ipg was explanted and replaced, restoring therapy post-operatively.

• Brand Name: PROCLAIM 5 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 stree; santana industrial park; arecibo PR 00612
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8970480
• MDR Text Key: 156771929
• Report Number: 3006705815-2019-03444
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: 3660
• Device Lot Number: A000070383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/21/2019; 10/14/2019; 11/19/2019
• Supplement Dates FDA Received: 09/26/2019; 10/28/2019; 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other