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

Model Number 3772

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier is unknown.Date of event is estimated.Date of implant is unknown.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 1627487-2020-23946, 1627487-2020-23947.It was reported that the patient experienced ineffective stimulation following a fall where the patient landed on their ipg pocket site.Imaging showed that the patient's leads had pulled-out of the ipg header.The patient underwent surgical intervention on (b)(6) 2020 to reconnect the leads.Intraoperative testing showed high impedances on multiple contacts.In turn, the physician decided to explant and replaced the entire scs system.Post-operatively, stimulation therapy was restored.

Manufacturer Narrative

The reported event of pull-out/connection problem was not confirmed.No root cause was identified for the reported event.

• Brand Name: PRODIGY MRI IPG, 16CH, 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
• MDR Report Key: 10400043
• MDR Text Key: 202683462
• Report Number: 3006705815-2020-30724
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• UDI-Public: 05415067017093
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2020
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: A000052186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS PADDLE LEAD (X2); SCS PADDLE LEAD (X2)
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 50