MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM TM 5 ELITE; SCS IPG

Model Number 3660

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

Patient Problems Edema (1820); Inflammation (1932); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed 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.

Event Description

The patient has multiple scs systems implanted and this report is related to the scs system implanted on (b)(6) 2016.It was reported that the patient experienced swelling and inflammation at the ipg site.The patient was given prophylactic antibiotics, although the surgeon confirmed that their was no infection.Patient underwent surgical intervention on (b)(6) 2017 to have their ipg pocket cleaned out and revised.

Event Description

Follow up revealed that the patients ipg was explanted (reference mfr report 1627487-2017-01965).The patient's pain has been resolved.

• Brand Name: PROCLAIM TM 5 ELITE
• Type of Device: SCS IPG
• 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: 6449664
• MDR Text Key: 71388097
• Report Number: 1627487-2017-01548
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• 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
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2018
• Device Model Number: 3660
• Device Lot Number: 5606907
• Other Device ID Number: 05415067020192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• 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
• Treatment: MODEL: 3228, SCS LEAD; MODEL: 3383, SCS EXTENSION (2)
• Patient Outcome(s): Other