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 Problem Rash (2033)

Event Type  Injury  

Event Description

Device 4 of 5: reference mfr.Report #: 3006705815-2018-03230; reference mfr.Report #: 3006705815-2018-03231; reference mfr.Report #: 3006705815-2018-03232; reference mfr.Report #: 1627487-2018-12723.It was reported that the patient has a rash across her lower back.The physician gave the patient oral antibiotics and plans to meet the patient at a later date.

Event Description

Device 4 of 5.Reference mfr.Report #: 3006705815-2018-03230.Reference mfr.Report #: 3006705815-2018-03231.Reference mfr.Report #: 3006705815-2018-03232.Reference mfr.Report #: 1627487-2018-12723.The "antibiotics" provided by the physician "has" cleared up the patient¿s rash.

• 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8138111
• MDR Text Key: 129489254
• Report Number: 1627487-2018-12721
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2019
• Device Model Number: 1192
• Device Lot Number: 6210786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• 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: 1192, SCS ANCHOR; MODEL: 3186, SCS LEAD (X2); MODEL: 3660, SCS IPG
• Patient Outcome(s): Other