MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTÉGÉ MRI¿ IPG, 16 CH, RECHARGEABLE; SCS IPG

Model Number 3771

Device Problems Self-Activation or Keying (1557); Device Stops Intermittently (1599)

Patient Problem Pain (1994)

Event Date 08/01/2015

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.(b)(4).

Event Description

It was reported the patient experienced stabbing pain at the ipg site only with stimulation on.The patient also stated the ipg had been turning on and off by itself.X-rays were taken but showed no anomalies.As a result, the ipg was explanted and replaced.The issue was resolved by surgical intervention.

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: PROTÉGÉ MRI¿ IPG, 16 CH, RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: lu han ; 6901 preston rd; plano, TX 75024 ; 9723098568
• MDR Report Key: 5028505
• MDR Text Key: 23968582
• Report Number: 1627487-2015-07476
• 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
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 3771
• Device Lot Number: 5035115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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: 54 YR