MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION CINCH LEAD ANCHOR; SCS ANCHOR

Model Number 1194

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion will be added in the final report.

Event Description

Device 2 of 5.Reference mfr.Report: 3006705815-2018-03342, reference mfr.Report: 3006705815-2018-03343, reference mfr.Report: 3006705815-2018-03344, reference mfr.Report: 1627487-2018-13113.It was reported the patient experienced drainage at the ipg and lead incision sites on (b)(6) 2018.The patient also reported feeling feverish and sick since (b)(6) 2018.Cultures were taken and the patient was prescribed antibiotics.

Event Description

Device 2 of 5.Reference mfr.Report: 3006705815-2018-03342 ,3006705815-2018-03343, 3006705815-2018-03344, 1627487-2018-13113.Follow-up information provided the patient underwent scs system explant (exact date unknown) due to infection.The patient does not have therapy.

Event Description

Device 2 of 5.Reference mfr.Report: 3006705815-2018-03342, 3006705815-2018-03343, 3006705815-2018-03344, 1627487-2018-13113.Additional information provided the infection has resolved.

Event Description

Device 2 of 5.Reference mfr.Report: 3006705815-2018-03342, 3006705815-2018-03343, 3006705815-2018-03344, 1627487-2018-13113.Additional information provided estimated explant date of (b)(6) 2018.

• Brand Name: CINCH LEAD 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: 8166987
• MDR Text Key: 130458895
• Report Number: 1627487-2018-13112
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024091
• UDI-Public: 05415067024091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081208
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2020
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 6498954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 02/06/2019; 03/29/2019; 03/29/2019
• Supplement Dates FDA Received: 02/21/2019; 04/05/2019; 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 69