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

Model Number 1192

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The event date is unknown.Concomitant medical products and therapy dates: model: 3186 (x2), scs leads, therapy date: unknown, model:#: 1192, scs anchor, therapy date: unknown the patient's weight was unable to be obtained.The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

Device 4 of 4; reference mfr.Report#: 3006705815-2020-01003; reference mfr.Report#: 3006705815-2020-01004; reference mfr.Report#: 1627487-2020-02352.It was reported one of the patient's leads had migrated and high impedance was present as a result.The patient later underwent surgical intervention and during the procedure the anchor associated with the lead that migrated was found to be broken.In turn, the physician decided to explant and replace both of the patient's leads and anchors to address the issue.Note: both of the patient's leads and anchors are being reported because it's unknown which devices were liable.

Manufacturer Narrative

The reported event of breakage was confirmed on one of the return anchors.Both anchors passed functional testing.The cause of the breakage is consistent with overstress condition the anchor was subjected while in vivo.

Event Description

Device 4 of 4: reference mfr.Report#: 3006705815-2020-01003.Reference mfr.Report#: 3006705815-2020-01004.Reference mfr.Report#: 1627487-2020-02352.

• 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: 9777643
• MDR Text Key: 181724737
• Report Number: 1627487-2020-02353
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6342722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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