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 Edema (1820); Pain (1994)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4)-the complaint of infection cannot be confirmed via laboratory testing.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

Device 4 of 4.Reference mfr.Reports: 1627487-2016-01082, 1627487-2016-01083 & 1627487-2016-01118.It was reported the patient went to the emergency room (er) due to experiencing two painful lumps, near the lead incision site.It was also reported the patient experienced a fall about one month prior to this event and was given an epidural a few days prior to this event due to experiencing a pulling sensation from her right low back to her stomach which occurred regardless of stimulation.Ct scans revealed subcutaneous edema around the lead incision sites.The patient received intra-venous antibiotics and was released from the er.Subsequently, the patient was referred to an infectious disease specialist.As of 02/26/2016, the patient's system was to be explanted as there was concern the sites were infected as the lumps had gone down but were "harder".No additional information is available at this time.

Event Description

Device 4 of 4.Reference mfr.Reports: 1627487-2016-01082, 1627487-2016-01083 & 1627487-2016-01118.Additional information received confirmed the patient's entire scs system was explanted.It was also clarified, the lumps were decreasing in size but became harder right before explant.Additionally, it was reported that per the patient, the lumps are resolving.

• 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
• MDR Report Key: 5480976
• MDR Text Key: 39734337
• Report Number: 1627487-2016-01119
• Device Sequence Number: 1
• Product Code: GZB
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 1192
• Device Lot Number: 4478840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2014
• 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: 55 YR