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

Model Number 3660

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

Date of 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 number 1627487-2020-31197.1627487-2020-31196.It was reported during the elective ipg replacement the leads extension were inserted in the header and in post -op the impedance was high so patient was taken back into the or were it was discovered that the one of the extension pull out of the ipg header the extension was reinserted resolving the issue.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot 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: 10515430
• MDR Text Key: 206350424
• Report Number: 3006705815-2020-31301
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000095034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS EXTENSION; SCS EXTENSION
• Patient Outcome(s): Other
• Patient Weight: 76