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 Problem Cardiopulmonary Arrest (1765)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

Abbott 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.Abbott defers to the patient¿s physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr.Report#: 3006705815-2017-01426.During ipg revision surgery (reference mfr.Report#1627487-2017-06076) it was reported the patient¿s 2 (model 3186) octrode leads were inadvertently pulled out of the epidural space due to the patient¿s breathing and iv difficulties.As a result, the physician opted to explant the leads.Reportedly, the physician was unable to advance new leads due to patient anatomy.In turn, the patient was referred to a neurosurgeon as the next course of action.

Event Description

Device 2 of 2: reference mfr.Report#: 3006705815-2017-01426.The physician being unable to advance the replacement leads was reported under mfr report: 1627487-2017-06104 and mfr report: 1627487-2017-06216.Additional information identified the patient underwent surgical intervention on (b)(6) 2017 where a paddle lead was implanted.

• 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: joanne story ; 6901 preston road; plano, TX 75024 ; 9725264875
• MDR Report Key: 6960012
• MDR Text Key: 89674572
• Report Number: 3006705815-2017-01427
• 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
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2019
• Device Model Number: 3186
• Device Lot Number: A000038512
• Other Device ID Number: 05415067017246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 53 YR