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

Model Number MN10450-50A

Device Problems Break (1069); Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)

Event Date 12/04/2020

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 number: 1627487-2020-48868.It was reported during a surgery on (b)(6) 2020 (manufacturer report number 1627487-2020-02670 and 1627487-2020-02671).The physician was unable to reinsert the right s3 lead into the ipg due to the distal contact being squished.The lead was explanted and replaced which resolved the issue.It is unknown which lead is liable, as such both leads are being reported.

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.

Manufacturer Narrative

This event cannot be confirmed or not confirmed for lead migration through product analysis testing alone.As received, resistance testing showed the returned lead passed the functional test.The cause of the reported event remains unknown.

Manufacturer Narrative

This event cannot be confirmed or not confirmed for lead migration through product analysis testing alone.As received, during visual microscopic investigation it was noted that there were 2 lead contacts damaged which would prevent lead insertion into an ipg.The cause of the reported event is consistent with damage during use.

• 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: 11019426
• MDR Text Key: 221755453
• Report Number: 1627487-2020-48867
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2020
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 6265448
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL MN10450-50A - DRG LEAD; MODEL MN10450-50A - DRG LEAD
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 100