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

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

Patient Problems Pain (1994); Weight Changes (2607)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

Device #2 of 2: reference mfr.Report: 162787-2015-03624.It was reported the patient is experiencing pain at the ipg and anchor sites.The patient experienced pocket pain after a recent long car ride.The patient has recently lost weight and the ipg has become more superficial.In addition, the patient is experiencing mid thoracic pain at the incision site where a neuroma has developed.Surgical intervention may be pending.Device information is unavailable.

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 #2 of 2: reference mfr.Report: 162787-2015-03624.Follow up information identified the patient underwent an injection and a nerve block, however; the patient continued to experience pain, hence surgical intervention has been postponed.The patient met with the sjm representative on (b)(6) 2016 and lead diagnostics showed no anomalies.The patient reports the pain has subsided and narcotic intake has decreased.

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 #2 of 2: reference mfr.Report: 162787-2015-03624.Follow up information identified the patient alleges that she is having to recharge her ipg more frequently.The sjm representative met with the patient and after assessment of the ipg pocket site and program parameters it may be a possibility that the frequency of recharging the ipg may be contributing to the pain.The sjm representative reprogrammed the ipg which should reduce the energy usage and reduce the recharge burden.Reprograming resolved the issue.

• 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 DIVISION; 6901 preston road; plano TX 75024
• MDR Report Key: 5792554
• MDR Text Key: 49491414
• Report Number: 1627487-2016-03625
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 79 YR