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

Model Number 3228

Device Problems Disconnection (1171); Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2019-05769.It was reported the patient experienced more sudden pain.Reportedly, when increasing the scs system amplitude stimulation occured only with high amplitude and sudden.Reprogramming was performed and found the system impedance was low, but the patient inform to have stimulation in the target area.X-ray taken showed the lead had slipped out from the ipg header port with contacts 1-8.Surgical intervention was planned to address the issue, but instead the physician removed the patient's scs ipg.No further information was available at this time.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for evaluation.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Reference mfr report(s): 1627487-2019-05769, 1627487-2019-07618 and 1627487-2019-07619.Additional information received identified the patient's surgical intervention occurred on (b)(6) 2019.During the procedure explant of the abbott scs ipg and both extensions was performed.The lead remained implanted and connected with adaptors and extensions of a competitor's company ipg.

• 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: 8618275
• MDR Text Key: 145340718
• Report Number: 1627487-2019-05768
• Device Sequence Number: 1
• Product Code: GZB
• 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: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 3228
• Device Lot Number: 5207775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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