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

Model Number 1192

Device Problem Break (1069)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.It is unknown which anchor broke.Hence, both the anchors are being reposted.

Event Description

Related manufacturer reference number: 3006705815-2020-00591.Related manufacturer reference number: 3006705815-2020-00592.Related manufacturer reference number: 1627487-2020-01458.It was reported that the patient lost therapy due to high impedance.As such, surgical intervention took place on (b)(6) 2020 where in the leads and anchors were explanted and replaced to address the issue.Reportedly, adequate therapy was restored post operatively.During the procedure, it was observed that both the leads and one of the anchors were broken.

Manufacturer Narrative

Both swift-lock anchors were post capa(b)(4) anchors.They were exercised between the locked and unlocked position.The returned leads and various lab leads were successfully inserted into the anchors.The locking mechanism of the anchor functioned as design.Both anchors passed functional testing and had no visible anomaly.The returned device confirmed normal device characteristics.In addition, anchor had no visible anomaly.Hence, this does not meet the reportability criteria.

• 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: 9716927
• MDR Text Key: 179921716
• Report Number: 1627487-2020-01459
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6832907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2019
• 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