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

Model Number 3186

Device Problem Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided on the final report.

Event Description

Device 2 of 2: reference mfr report: 3006705815-2018-03161.It was reported that the patient was unable to put their ipg into mri mode due to low impedances.As a result, surgical intervention may be pending.

Event Description

Device 2 of 2.Reference mfr report: 3006705815-2018-03161.Follow up revealed that the patient underwent surgical intervention on (b)(6) 2019 to have their ipg and leads repositioned.Issue has been resolved.

• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8148526
• MDR Text Key: 129834985
• Report Number: 3006705815-2018-03162
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2019
• Device Model Number: 3186
• Device Lot Number: A000048165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2017
• 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: MODEL: 3186, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 44 YR