MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG SLIM TIP LEAD

Model Number MN10450-90A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer reference number: 1627487-2020-31874.Patient complained therapy had been lost.X-rays were taken and indicated the leads implanted at the l3 and l5 vertebral levels are fractured and had migrated.Patient denied any falls or trauma, but that she was quite active.Surgical intervention is slated to take place at a later date to replace the leads.

Event Description

Additional information received indicated the patient underwent surgical intervention wherein the leads were explanted and replaced.Effective therapy was established post-op.

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: KIT IMPLANTABLE SLIM TIP LEAD, 90CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10584555
• MDR Text Key: 208506169
• Report Number: 1627487-2020-31873
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025548
• UDI-Public: 05415067025548
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2019
• Device Model Number: MN10450-90A
• Device Catalogue Number: MN10450-90A
• Device Lot Number: AB2255
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL MN10450-90A; MODEL MN10450-90A
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 50