MAUDE Adverse Event Report: ST. JUDE MEDICAL ¿ NEUROMODULATION OCTRODE; SCS LEAD

Model Number 3189

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Inadequate Pain Relief (2388)

Event Date 07/15/2014

Event Type  Injury  

Event Description

Device 1 of 2 reference mfr.Report #: 1627487-2014-25632.It was reported the patient ((b)(6)) was experiencing painful stimulation and muscle spasms due to a possible lead migration of the left lead.Additionally, it was reported the patient was hospitalized from (b)(6) 2014.During the patient's hospitalization, surgical intervention was undertaken to reposition the lead which resolved the issue.The date of the procedure is unknown at this time.Since it is also unknown which lead was repositioned both lead are being reported.

Manufacturer Narrative

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.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL ¿ NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 4144055
• MDR Text Key: 4930585
• Report Number: 1627487-2014-25631
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/11/2014

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: 10/01/2015
• Device Model Number: 3189
• Device Lot Number: 4308135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: SCS IPG: MODEL: 3788
• Patient Outcome(s): Hospitalization