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

Model Number 3660

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  Injury  

Event Description

Related manufacturer report number: 1627487-2024-06978.This event was reported by the patient via medwatch form number mw5149661.Reporter calling to report problems with her implanted abbott device.Reporter states that her device will not go into "mri mode".Reporter states that an abbott representative assisted her and even they were unable to get the device to go into mri mode.Reporter states that she needs to have an mri of her brain but she cannot get one due to this malfunction with her device.Reporter states problems with the device began "about two years ago" and states the device will shock her at random times and "makes my legs jump." reporter states that due to this, she loses her balance "a lot" and states that her husband has helped prevent her from falling down numerous times.Reporter states she wants abbott to "find a resolution" for the programming problems with her device because she needs to have an mri.Reference report: mw5149660 surgical intervention is planned to replace the scs system.

Manufacturer Narrative

Date of event is estimated.

Event Description

Additional information was received that surgical intervention was undertaken wherein it was observed that the patient's lead was fractured.The patient's system was replaced and effective therapy was restored postoperatively.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to 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
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18717367
• MDR Text Key: 335521393
• Report Number: 3006705815-2024-01271
• Device Sequence Number: 1
• Product Code: LGW
• 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: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3660
• Device Lot Number: A000128624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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
• Treatment: SCS LEAD.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 78 KG