MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44C LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3245

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

Patient Problem Muscle Spasm(s) (1966)

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report #: 1627487-2015-07041.

Event Description

Device 1 of 2.Reference mfr report #: 1627487-2015-07041.It was reported the patient experienced muscle spasms regardless of stimulation being on or off.The event date is unknown.It was found the patient had a knot on her low back which was unrelated to the stimulator per the doctor.The doctor ordered a ct for diagnostic purposes, but the patient refused and requested to have the scs system explanted.As a result, the scs system was explanted.

Event Description

Device 1 of 2.Reference mfr report #: 1627487-2015-07041.

Manufacturer Narrative

Udi (di): (b)(4).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.

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.

Manufacturer Narrative

Results : the complaint could not be confirmed for muscle spasms.Visual inspection and functional testing did not show any anomalies.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: LAMITRODE 44C LEAD KIT, 60CM 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: 4520936
• MDR Text Key: 5469999
• Report Number: 1627487-2015-07040
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2015

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: 11/28/2015
• Device Model Number: 3245
• Device Lot Number: 4363399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 02/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/12/2015; 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2013
• 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: MODEL: 3789, SCS IPG; MODEL: 1192, SCS ANCHOR
• Patient Outcome(s): Other