MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) IPG, 5.3AH, SCS PC NEW; SCS IPG

Model Number 3670

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2023

Event Type  Injury  

Event Description

It was reported that during lead revision surgery on (b)(6) 2023 (related manufacturer report number: 1627487-2023-02234) the physician experienced issues releasing the lead tails from the header.As a result, the ipg was explanted and replaced to address the issue.

Manufacturer Narrative

Date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

The report that the ¿lead tails were stuck in the header¿ was not able to be confirmed.The ¿as received¿ condition of the ipg header found it was severely damaged, during the explant procedure, and the root cause of the alleged stuck lead tails was not able to be ascertained due to this damage.The ipg communicated with lab utilities and logs were extracted.

• Brand Name: IPG, 5.3AH, SCS PC NEW
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17283161
• MDR Text Key: 318641898
• Report Number: 3006705815-2023-04179
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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 Model Number: 3670
• Device Catalogue Number: 3670
• Device Lot Number: A000129395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 77 KG