MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 1627487-2020-48102, 1627487-2020-48103.It was reported the patient experienced impedance issues on both leads.One of the leads had pulled out of the ipg header.Surgical intervention took place in which the system was explanted and replaced.Therapy was restored.

Manufacturer Narrative

Correction: h6 device code should have been 1371 rather than 1171.As received, a lab lead could be fully inserted into each port without any resistance encountered.Normal pairing and bluetooth (ble) communication was observed.The ipg was functionally tested on ate on all passed all tests.Both ports of the ipg also passed a lead fitment test.The ipg functioned as intended.The issue could not be replicated.It was reported imaging showed the leads were not fully inserted into the header of the ipg.This would have caused changes in stimulation output as well as the impedance issues observed in the field.However, the images were not received.The root cause of the issue could not be determined.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 10884862
• MDR Text Key: 217668136
• Report Number: 3006705815-2020-32881
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• 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
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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: 03/25/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000095315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL # 3186 - LEAD (X2); MODEL # 3186 - LEAD (X2)
• Patient Outcome(s): Other
• Patient Weight: 79