MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD

Model Number 3228

Device Problem Unintended Electrical Shock (4018)

Patient Problem Device Overstimulation of Tissue (1991)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided on the final report.

Event Description

Device 1 of 2.Reference mfr report: 3006705815-2019-00103.It was reported that the patient underwent an mri without being in mri mode.As a result, the patient experienced shock in their legs.The ipg is still operable post mri.

Manufacturer Narrative

The patient was implanted sometime in (b)(6) 2017.

Event Description

Device 1 of 2.Reference mfr report: 3006705815-2019-00103.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8222851
• MDR Text Key: 132250234
• Report Number: 1627487-2019-00402
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2017
• Device Model Number: 3228
• Device Lot Number: 5222324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2015
• 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