MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG SLIM TIP LEAD

Model Number MN10450-50A

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

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 reference# 1627487-2020-32268, 1627487-2020-32269, 1627487-2020-32267 it was reported the patient was receiving inadequate stimulation.An impedance check revealed high impedance on two leads.Reprogramming was able to provide sufficient therapy.However, the patient may undergo surgical intervention on a later date.All of the patient's leads are being reported because it is unknown which leads are liable.

Event Description

Follow-up information indicated the physician explanted and replaced two leads.This issue is now resolved.

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, 50CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10646830
• MDR Text Key: 210364768
• Report Number: 1627487-2020-32270
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 7034968
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/22/2020; 12/01/2020
• Supplement Dates FDA Received: 10/27/2020; 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG LEAD (3); DRG LEAD (3)
• Patient Outcome(s): Other
• Patient Weight: 75