MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.

Event Description

Related manufacturer reference number: 3006705815-2020-30486.Patient initially reported error in setting ipg to mri mode.Troubleshooting was done and found high impedance on lead contacts.Reprogramming was done to obtain full therapy coverage however physician is planning to do a revision surgery in the future.

Manufacturer Narrative

Additional information: a4 - patient weight.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Additional information: h6 - method code: 4117 has been updated to 4114.

Event Description

Additional information was received that surgery occurred during which the leads were explanted and replaced to address the issue.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• 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: 10353840
• MDR Text Key: 201359234
• Report Number: 3006705815-2020-30487
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2020
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000055321
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3186 - LEAD
• Patient Outcome(s): Other
• Patient Weight: 109