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

Model Number 3660

Device Problem Wireless Communication Problem (3283)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

Event Description

It was reported that the implantable pulse generator was inoperable.Patient lost therapy.Patient underwent an unrelated surgery and did not place the device in surgery mode.A surgical intervention is anticipated in the near future.No additional information is available at this time.

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.The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information was received indicating that the patient's ipg was recovered by an abbott representative and therapy was restored to the patient.

Manufacturer Narrative

The "report type" has been changed to "malfunction".Section b1: uncheck "adverse event".Section b2: uncheck "other serious (important medical events)".Section h7: remedial action unchecked and removed.Section h9: fsca has been removed due to the ipg being recovered.An inoperable ipg was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery was used.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Based on the information received, the cause of the reported incident is consistent with unintentional damage during the unrelated surgery.The system was recovered through abbott intervention.The ipg was not replaced to reestablish effective therapy.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 13013272
• MDR Text Key: 282328854
• Report Number: 3006705815-2021-06271
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2021
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000090206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Treatment: SCS LEAD X2
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 95 KG