MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

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

Patient Problems Apnea (1720); Muscle Spasm(s) (1966); Loss of consciousness (2418)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Device #2 of 2: reference mfr.Report: 1627487-2015-26381.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 5001811
• MDR Text Key: 22938956
• Report Number: 1627487-2015-26382
• 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
• Reporter Occupation: Other
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 3189
• Device Lot Number: 4950468
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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 3716, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 64 YR