MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

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

Patient Problems Erosion (1750); Discomfort (2330); Weight Changes (2607)

Event Date 11/29/2014

Event Type  Injury  

Event Description

The patient is implanted with a scs system which includes two anchors from same lot.It was reported the patient experienced pain due to the scs anchors eroding through the skin.It was also stated the patient lost significant amount of weight.The patient underwent surgical intervention to remove the anchors and the leads were sutured to the muscle.Reportedly, the patient's wound had healed.

Manufacturer Narrative

(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.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• 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: 4845803
• MDR Text Key: 16188379
• Report Number: 1627487-2015-26251
• 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: 05/28/2015

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: 08/28/2014
• Device Model Number: 1192
• Device Lot Number: 3768687
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2012
• 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 3186, SCS LEAD; MODEL 3789, SCS IPG; MODEL 3286, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 28 YR