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 Bacterial Infection (1735); Erythema (1840); Fluid Discharge (2686)

Event Date 07/09/2016

Event Type  Injury  

Manufacturer Narrative

The complaint of streptococcus cannot be confirmed via laboratory testing.(b)(4).Sjm 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.Sjm defers to the patient¿s physician regarding medical history.(b)(4).

Event Description

The patient had two anchors from the same lot.Device 4 of 4.Reference mfr report #: 1627487-2016-04038, 1627487-2016-04039 and 1627487-2016-04123.It was reported the patient had a trial procedure on (b)(6) 2016.Following the procedure, the patient experienced drainage at the extension site and went to the emergency room where the dressing of the extension site was changed.On (b)(6) 2016, it was noted by the physician that the extension incision site looked red and infected.As a result, the lead was explanted and the patient was given antibiotics.Cultures were taken at the time and the results came back positive for a type of streptococcus.Follow-up revealed the patient was still on antibiotics.

Manufacturer Narrative

Sjm 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.Sjm defers to the patient¿s physician regarding medical history.

Event Description

Device 4 of 4.Reference mfr report #: 1627487-2016-04038, 1627487-2016-04039 and 1627487-2016-04123.Follow-up revealed the patient was continuing to be on antibiotics and the physician believed it would resolve the infection.

Manufacturer Narrative

Sjm 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.Sjm defers to the patient¿s physician regarding medical history.

Event Description

Device 4 of 4: reference mfr report #: 1627487-2016-04038, 1627487-2016-04039 and 1627487-2016-04123.

• 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
• MDR Report Key: 5869451
• MDR Text Key: 51877523
• Report Number: 1627487-2016-04124
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK081208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2016

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: 10/31/2017
• Device Model Number: 1194
• Device Lot Number: 5298320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/23/2016; 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2015
• 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 Age: 51 YR