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

Model Number 3660

Device Problems Output above Specifications (1432); Inappropriate/Inadequate Shock/Stimulation (1574); Temperature Problem (3022)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Burning Sensation (2146); Implant Pain (4561)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient experienced pain and heating at the pocket site.As a result, surgery may occur to address the issue.

Event Description

Additional information was received that the patient was also experiencing a shocking sensation at the ipg site.As a result of the reported issues, surgery occurred to explant and replace the ipg, which resolved the issue.

Manufacturer Narrative

The report of pain / shocking at ipg site was not confirmed.Analysis of the returned ipg found that it had no physical anomalies, it passed all functional testing, and it communicated with all lab utilities.Discomfort or pain at the ipg site is commonly associated with patient anatomy and/or the location of the ipg pocket site.There was no mention in the report if the pocket site was relocated during the revision procedure.The patient did not report any falls or trauma prior to the revision.The returned ipg exhibited normal device characteristics during analysis.The reported heating at the pocket site was also not confirmed.The returned device was tested and met the product requirement specification for heat generation during use.During analysis no anomalies were identified that would have existed prior to explant that would have contributed to the alleged heat generation complaint.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• 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
• MDR Report Key: 10702772
• MDR Text Key: 212056668
• Report Number: 3006705815-2020-32089
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000095130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 01/27/2021
• Supplement Dates FDA Received: 11/16/2020; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 84