MAUDE Adverse Event Report: IMPULSE DYNAMICS USA, INC. OPTIMIZER SMART MINI; IMPLANTABLE PULSE GENERATOR

Model Number CCM X11

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 03/19/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, an implanting physician called an impulse dynamics (id) field representative about a patient who had been implanted with an optimizer smart mini (osm) implantable pulse generator (ipg) on (b)(6) 2024.The patient was still hospitalized due to what the physician described as "post-operative pain".The field rep arrived at the hospital later that morning, and the patient complained of left-sided chest pain at the site of the incision.The patient described the feeling as a "muscle squeezing tightly into my neck".At the time of the visit, the patient's ipg was not actively delivering therapy (i.E.Not in an active delivery cycle).When a full device interrogation was attempted on the ipg, the patient refused and demanded that the device be removed.Similar attempts to temporarily turn off the device or make adjustments to the treatmen/delivery cycles were refused.The implanting physician was informed of this as the rep was bedside with the patient, and the patient's ipg was removed/explanted later that day.After the ipg was sent and passed through pathology at the hospital, the device was given to the rep who then transported the device to impulse dynamics, usa in (b)(6), new jersey for further evaluation.Upon receipt at id usa on (b)(6) 2024, the ipg was x-rayed within the sealed bag, and no abnormalities were observed.Similarly, no anomalies were found during the review of device sterilization records.The device was then sent to an approved decontamination facility that same day.The ipg has not yet been received back from decontamination, but once it has, it will be inspected more closely and run through electronic controls testing to confirm functional status at the time of explant.

• Brand Name: OPTIMIZER SMART MINI
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): IMPULSE DYNAMICS USA, INC.; 401 route 73 n; bldg 50, ste 110; marlton NJ 08053
• Manufacturer Contact: robert fasciano ; 401 route 73 n; bldg 50, ste 110; marlton, NJ 08053 ; 6174359098
• MDR Report Key: 19136013
• MDR Text Key: 340566984
• Report Number: 3012563838-2024-00017
• Device Sequence Number: 1
• Product Code: QFV
• UDI-Device Identifier: 00810003380098
• UDI-Public: 00810003380098
• Combination Product (y/n): N
• PMA/PMN Number: P180036/S007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

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 Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H5073
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female