MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD

Model Number 3228

Device Problem Disconnection (1171)

Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 12/16/2019

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: 1627487-2020-02553; related manufacturer reference number: 1627487-2020-02554; related manufacturer reference number: 3006705815-2020-01089.It was reported that the patient¿s stimulation kept stopping on its own.Additionally, patient reported sometimes experiencing electrical sensations at the lead/extension connection site.Diagnostics revealed high impedances.X-ray revealed that one of the lead tails was not completely inserted into the extension.Reprogramming was unable to resolve the issue.As such, surgical intervention took place on (b)(6) 2020.During intra-op, impedance reading was normal on the lead and extension.However, the impedance reading was high when measured on the entire system.The extensions were replaced with new extensions, but the issue persisted.In turn, the ipg was also explanted and replaced with a ipg to address the issue.No intervention took place on the lead.

Manufacturer Narrative

(b)(6).

Event Description

Additional information received indicates that the physician experienced difficulty inserting the new extensions into the ipg and the high impedance persisted.In turn, the ipg was also explanted and replaced with a ipg resolving the issue.Reportedly therapy was resumed.

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: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9809123
• MDR Text Key: 182734813
• Report Number: 1627487-2020-02552
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 5661274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other