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

Model Number 3186

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

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2015-23752.It was reported the patient's leads had migrated.It was also reported the patient experienced a fall.Subsequently, the patient underwent surgical intervention where the 2 leads were explanted and replaced with a single lead (different model).The patient reported effective stimulation coverage postoperative.Please note: the event date is unknown.

• Brand Name: OCTRODE 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: 5333132
• MDR Text Key: 34639864
• Report Number: 1627487-2015-23751
• 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
• Report Date: 12/07/2015

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: 02/28/2017
• Device Model Number: 3186
• Device Lot Number: 5024974
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• 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 3688, SCS IPG
• Patient Outcome(s): Other