MAUDE Adverse Event Report: ABBOTT MEDICAL IMPLANTABLE NEUROSTIMULATOR KIT; DRG INS

Model Number MN10200

Device Problem Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 12/17/2020

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

Reference manufacturer numbers: 1627487-2021-00092, 1627487-2021-00093.It was reported that the patient may undergo surgical intervention to explant their scs system.Further information regarding this event is unknown at this time and will be provided when available.Since it is not known which device contributed to the issue, all possible devices are being reported on.

Manufacturer Narrative

A patient is awaiting a system explant for an unknown reason was reported to abbott.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR KIT
• Type of Device: DRG INS
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11117637
• MDR Text Key: 225096229
• Report Number: 1627487-2021-00091
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025500
• UDI-Public: 05415067025500
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2019
• Device Model Number: MN10200
• Device Catalogue Number: MN10200
• Device Lot Number: DB6853
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL MN10450-50A, DRG SLIM TIP LEAD X2; MODEL MN10450-50A, DRG SLIM TIP LEAD X2
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 75