MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

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

Patient Problems Wound Dehiscence (1154); Erythema (1840); Fluid Discharge (2686)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.Sjm has limited information related to the patient¿s medical history and is unable to form an opinion as to the relevancy of the patient¿s history to the event reported.Sjm defers to the patient¿s physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr number: 3006705815-2017-00909.It was reported the patient experienced redness at the mid back incision site and the ipg site in addition to burning sensation at the ipg site.A pin point open area was noted along the scar and was draining white fluid.As a result, the patient underwent surgical intervention on (b)(6) 2017.During the procedure, the ipg was explanted and the lead was cut.Culture was taken from the ipg site.The patient was given antibiotics.Follow-up revealed the patient was healing.

Event Description

Device 2 of 2.Reference mfr number: 3006705815-2017-00909.Follow-up identified the patient's incision continues to heal at this time.

Event Description

Device 2 of 2.Reference mfr number: 3006705815-2017-00909.

Event Description

Device 2 of 2.Reference mfr number: 3006705815-2017-00909.Additional information received identified the issue has resolved.

Event Description

Device 2 of 2.Reference mfr.Report#: 3006705815-2017-00909.Additional information revealed the patient underwent surgical intervention on (b)(6) 2017, wherein the ipg and the cut lead was removed and replaced after redness was noticed near the incision site.The patient's site healed successfully and the redness has also vanished.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• 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: lu han ; 6901 preston road; plano, TX 75024 ; 9723098568
• MDR Report Key: 6727578
• MDR Text Key: 80512791
• Report Number: 3006705815-2017-00879
• Device Sequence Number: 1
• Product Code: GZB
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/21/2017

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: 05/05/2018
• Device Model Number: 3186
• Device Lot Number: 5495691
• Other Device ID Number: 05415067017246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 08/04/2017; 08/07/2017; 10/06/2017; 11/01/2017
• Supplement Dates FDA Received: 08/11/2017; 08/28/2017; 11/01/2017; 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2016
• 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 Age: 60 YR