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

Model Number 3186

Device Problems High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

Date of event and therapy date are estimated.

Event Description

Related manufacturer reference number: 3006705815-2021-03811.It was reported that the patient lost effective therapy, and high impedances were measured at a lead contact.Reprogramming did not resolve the issue.As a result, surgery may occur to address the issue.It is not known which of the two leads had the high impedance contact, so both applicable leads are being reported.

Event Description

Additional information was received that surgery occurred on 10aug2021 in which the leads were repositioned, which resolved the issue.

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.

• 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: 12283938
• MDR Text Key: 265275235
• Report Number: 3006705815-2021-03812
• 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
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000092036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD; SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 159