MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION RENEW RECEIVER; SCS IPG

Model Number 3416

Device Problems Low Battery (2584); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2014

Event Type  Injury  

Event Description

It was reported the programmer was unable to communicate with her cervical ipg.Surgical intervention may be pending to address this issue.

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.

• Brand Name: RENEW RECEIVER
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4112620
• MDR Text Key: 4938345
• Report Number: 1627487-2014-26732
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2014
• 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
• Treatment: SCS LEAD: MODEL 3186 (2); IMPLANT DATE:; SCS EXTENSION: MODEL 3382; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 52 YR