MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION KIT LEAD EXTENSION, 50CM; DRG EXTENSION

Model Number MN10550-50

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer report number: 1627487-2020-23576.It was reported the patient was experiencing pain near the extension site.It was noted the patient had lost weight recently.As a result, the patient may undergo surgical intervention to address the issue.

Event Description

Additional information received indicates that the patient underwent surgical intervention during which their system was explanted.The patient was stable post-operatively.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.During processing of this complaint, attempts were made to obtain complete patient information.

• Brand Name: KIT LEAD EXTENSION, 50CM
• Type of Device: DRG EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10382343
• MDR Text Key: 202166444
• Report Number: 1627487-2020-23577
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027177
• UDI-Public: 05415067027177
• 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
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2020
• Device Model Number: MN10550-50
• Device Catalogue Number: MN10550-50
• Device Lot Number: 6367640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG EXTENSION
• Patient Outcome(s): Other
• Patient Age: 38 YR