MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6662

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

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)

Event Date 02/02/2024

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2024-07140 and 1627487-2024-07139.It was reported that patient experienced infection at ipg site and extensions.It was also noted that the ipg had eroded through the skin and there was redness and drainage at ipg site.Patient was given iv antibiotics.Surgical intervention was undertaken wherein both extensions were explanted and replaced.The ipg was also explanted, replaced and the pocket was relocated.Therapy was restored.

Manufacturer Narrative

Section b3: date of event is estimated.

Event Description

Additional information indicated that the infection has cleared/resolved, and incision sites have healed well.

Manufacturer Narrative

A patient experienced infection at ipg site and extensions was reported to abbott.It was determined the ipg had eroded through the skin and there was redness and drainage at ipg site.The patient was given iv antibiotics.Surgical intervention was undertaken wherein both extensions were explanted and replaced.The ipg was also explanted, replaced and the pocket was relocated.Therapy was restored.The infection has cleared/resolved, and incision sites have healed well.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS 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: 18759597
• MDR Text Key: 336010164
• Report Number: 3006705815-2024-01471
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• 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,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6662
• Device Lot Number: A000143982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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
• Treatment: DBS BURR HOLE CAP (2); DBS LEAD (2)
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 84 KG