MAUDE Adverse Event Report: ST. JUDE MEDICAL, NEUROMODULATION LAMITRODE S8

Model Number 3286

Device Problem Detachment Of Device Component (1104)

Patient Problems Erosion (1750); Swelling (2091); Inadequate Pain Relief (2388)

Event Date 09/17/2013

Event Type  Injury  

Event Description

It was reported the patient had fallen, and also had turned his head and felt a pop in this neck where the occipital lead was implanted (off-label use).Reprogramming was able to regain stimulation coverage, but the area was tender and there was some swelling at the lead site.Initial x-rays did not show migration.Add'l f/u regarding the patient status identified the lead was poking through the skin and the site had eroded.It was reported the patient had diabetes, and there was a concern it was not under control.The patient had been placed on antibiotics, and the physician opted to remove half of the lead which included the paddle portion.During the procedure the physician opted to leave the ipg, the extension, and the lead terminal end implanted.The physician determined one contact on the lead was dislodged and remained within the patient during the explant procedure.Under fluoroscopy, the contact was located, but the physician opted not remove the contact since it was not close to the incision.The physician planned to allow the patient to heal before the next course of action.

Manufacturer Narrative

Sjm has limited info 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 S8
• Manufacturer (Section D): ST. JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer st. clair ; 6901 preston rd.; plano, TX 75024 ; 9725264677
• MDR Report Key: 3674183
• MDR Text Key: 4303013
• Report Number: 1627487-2014-04008
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/10/2013

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2013
• Device Model Number: 3286
• Device Lot Number: 3486370
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/31/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• 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 EXTENSION: MODEL 3386; IMPLANT DATE:; SCS IPG, MODEL 3788; IMPLANT DATE:; SCS ANCHOR: MODEL 1192; IMPLANT DATE:; SCS EXTENSION, MODEL 3383; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 58 YR