MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 20CM; SCS EXTENSION

Model Number 3342

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

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:1627487-2020-23290.It was reported that during an elective surgery to replace the ipg on (b)(6) 2020, the physician broke a lead.In turn, the terminal end of the lead was stuck in the explanted ipg header.The broken tail of the lead was left in the ipg pocket.Therapy was successfully restored post-op.

Manufacturer Narrative

During an elective surgery to replace a patient's ipg, the physician broke a lead was reported to abbott.As a result, the lead in the 1-8 port was plugged into the new ipg and a port plug was used for the 9-16 port; the broken tail of the lead in the 9-16 port of the ipg was left in the ipg pocket.Therapy was restored.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 event could not be conclusively determined.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 20CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10335959
• MDR Text Key: 200761086
• Report Number: 1627487-2020-23291
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• 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: 09/08/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2011
• Device Model Number: 3342
• Device Lot Number: 2841269
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD
• Patient Outcome(s): Other
• Patient Weight: 84