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); Unspecified Infection (1930); Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: model 3662, scs ipg, model 3186 (x2), scs lead, model 1192, scs anchor.Therapy dates: unknown.Further information was requested but unable to obtain.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 2 of 5.Reference mfr report: 1627487-2019-05018, reference mfr report: 3006705815-2019-01560, reference mfr report: 3006705815-2019-01561, reference mfr report: 1627487-2019-05020.It was reported that the patient had a suspected infection.As a result, the patient underwent an incision and drainage procedure on (b)(6) 2019.The physician assessed the suspected area and debridement.Reportedly the physician found that the suspected area was superficial and saw no real signs of infection.The wound was cultured and no infection was present.Issue resolved.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2019-05018; related manufacturer reference number: 3006705815-2019-01560; related manufacturer reference number: 3006705815-2019-01561; related manufacturer reference number: 1627487-2019-05020.New information received indicated that the lead wire at ipg site was exposed and an infection was suspected.In turn, surgical intervention was undertaken on (b)(6) 2019 wherein the entire system was explanted to address the issue.

Event Description

Device 2 of 5.Reference mfr report: 1627487-2019-05018.Reference mfr report: 3006705815-2019-01560.Reference mfr report: 3006705815-2019-01561.Reference mfr report: 1627487-2019-05020.

Manufacturer Narrative

The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 1627487-2019-05018.Related manufacturer reference number: 3006705815-2019-01560.Related manufacturer reference number: 3006705815-2019-01561.Related manufacturer reference number: 1627487-2019-05020.

• 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: 8558421
• MDR Text Key: 143374951
• Report Number: 1627487-2019-05019
• 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,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 1192
• Device Lot Number: 5836522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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
• Patient Outcome(s): Other
• Patient Weight: 91