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

Model Number 3660

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Burning Sensation (2146); Post Operative Wound Infection (2446); Swelling/ Edema (4577)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

Dat e of event: date of event is estimated.

Event Description

It was reported the patient experienced redness, swelling and warmth to her ipg site.Further diagnostics indicated the patient had an infection.Patient was placed on antibiotics.Surgical intervention may be pending to address the issue at a later date.

Manufacturer Narrative

Correction: h6 clinical code should have been 2446 post operative wound infection instead of 1930 unspecified infection.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

Event Description

Additional information indicates the patient's symptoms at the ipg site have resolved.

• 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: 12076759
• MDR Text Key: 258683464
• Report Number: 3006705815-2021-03163
• 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
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000109005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 89