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 Erythema (1840); Itching Sensation (1943); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 4 of 5: reference mfr report#1627487-2018-10470, reference mfr report#3006705815-2018-02806, reference mfr report#3006705815-2018-02807, reference mfr report#1627487-2018-10647.It was reported that the at the follow-up visit post implant (wound care checkup) patient reported redness, burning and extreme itching at both the lead and ipg surgical sites.Reportedly, no drainage, fever or chills were reported.The patient was prescribed prophylactic antibiotic as a precaution for infection or cellulitis, but the physician believed it was more likely an allergic reaction to the surgical glue and therefore prescribed anti-histaminic.Follow up visit identified that patient symptoms were reduced.Antibiotic course completed and no additional medications were prescribed.Patient symptoms have reportedly resolved.

Event Description

Device 4 of 5: reference mfr report#1627487-2018-10470; reference mfr report#3006705815-2018-02806; reference mfr report#3006705815-2018-02807; reference mfr report#1627487-2018-10647.Additional information received identified that patient was admitted to the emergency room (er) (b)(6) 2018 night for further evaluation for possible infection.Reportedly, patient had fever with chills of 102 degrees for 2 to 3 days and unrelenting headache prior to the er visit.Reportedly, patient¿s wife noted a small swelling near the incision (site unknown).Patient underwent a ct scan of the thoracic spine which was inconclusive.Patient is currently admitted and is on antibiotics.

Event Description

Device 4 of 5.Reference mfr report#1627487-2018-10470.Reference mfr report#3006705815-2018-02806.Reference mfr report#3006705815-2018-02807.Reference mfr report#1627487-2018-10647.Additional information revealed that patient had suffered a staph infection.As a result, the patient's system was explanted on (b)(6) 2018.Patient is currently being treated by an infectious disease physician.

• 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: 8058018
• MDR Text Key: 126887592
• Report Number: 1627487-2018-10644
• 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,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2020
• Device Model Number: 1192
• Device Lot Number: 6461505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• 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
• Patient Outcome(s): Other