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 Inadequate Pain Relief (2388)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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.

Event Description

Related manufacturer reference number: 3006705815-2021-01535, 1627487-2021-12883.It was reported that one of the patient's leads pulled out from the ipg after patient had a fall.The lead pullout was confirmed via x-rays.Surgery took place on (b)(6) 2021 wherein the pulled lead was repositioned back into the ipg.It is not known which lead pulled out from ipg, so both leads are being reported.During the procedure, the ipg header broke while lead was being put back into the ipg.As a result, the ipg was also explanted and replaced.

Manufacturer Narrative

The reported lead pull out was not confirmed.X-ray images were not returned.Visual inspection of the ipg did not identify any anomalies that would contribute to the reported issue.It passed a lead fitment and lead retention tests.The reported issue could not be replicated.The ipg passed all functional tests when tested on ate.The ipg displayed normal device characteristics.No physical or functional anomaly that would contribute to the reported issue was observed.A lead pull out would be consistent with the lead being subjected to tensile stress , such as that experienced with a fall; however, this could not be conclusively 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: 11610752
• MDR Text Key: 243724818
• Report Number: 3006705815-2021-01536
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000093913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD X2
• Patient Outcome(s): Other
• Patient Weight: 59