MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM ELITE 7; SCS IPG

Model Number 3662

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

Patient Problem Wound Dehiscence (1154)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturer evaluation: the reported event cannot be analyzed via laboratory testing.(b)(4).

Event Description

It was reported the patient went to the er due to pain at the ipg site.The physician saw the patient and noted a wound that was open enough to see the ipg.The physician also noted wound dehiscence and cultures were taken.The patient's devices were explanted.The surgeon reported no sign of infection.Oral antibiotics were given prophylactically.

• Brand Name: PROCLAIM ELITE 7
• 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: 6355256
• MDR Text Key: 68210228
• Report Number: 1627487-2017-00851
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2018
• Device Model Number: 3662
• Device Lot Number: 5678848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2016
• 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 3224, SCS LEAD
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR