MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Emotional Changes (1831); Hyperthermia (1909); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Rash (2033); Distress (2329); Malaise (2359); Sore Throat (2396); Diaphoresis (2452); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2022

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an unknown source regarding a patient who was receiving 2000mcg/ml of lioresal at an unknown dose via an implantable pump. On (b)(6) 2022(local time (b)(6) 2022), it was reported that the patient's pump was giving off a critical alarm. The pump was interrogated by the managing physician and a service code 100, indicative of a motor stall, was detected. It was unknown what, if any, environmental/external/patient factors that might have led or contributed to the issue. No interventions were taken to manage the motor stall. The patient was treated for acute baclofen withdrawal. However, the patient passed away on (b)(6) 2022 (local time). The issue was not considered resolve that the time of the report. No surgical intervention had occurred or was planned. The patient's cause was death was being investigated by the coroner. Additional information was received from the foreign healthcare provider (hcp) via the manufacturer's representative (rep) on (b)(6) 2022. It was confirmed that the patient's death was thought to be related to the device or therapy. This was because the patient was admitted with a pump emitting a critical alarm which upon interrogation showed a motor stall event. The patient was reported to have displayed symptoms of acute baclofen withdrawal and deteriorated rapidly despite the administration of stabilizing medication. The cause of death had not yet been determined. The pump was explanted. Additional information was received from the foreign healthcare provider (hcp) via a manufacturer's representative (rep) on 2022-mar-16. It was confirmed that the motor stall, that was noted on (b)(6) 2022 (local time), did not recover. The cause of the motor stall was unknown and no mri was performed around the time of the motor stall. The device was interrogated but normal function was could not be recovered. It was again reported that the patient died subsequent to the motor stall. The pump was explanted on (b)(6) 2022. It was noted that it was unknown what interventions were taken with respect to the acute baclofen withdrawal and it was unknown if there were any other medical events/procedures leading up to the patient's death. It was also unknown what, if any, symptoms the patient experienced. The patient was not hospitalized prior to their passing. Additional information was received from a foreign healthcare professional (forensic pathologist). The patient had died on (b)(6) 2022 and the pump was removed at autopsy on (b)(6) 2022. The cause of the pump¿s failure was unknown at this point and was why the case was referred to the coroner. They were in the process of obtaining permission from the coroner to release further information about the case.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13932997
• MDR Text Key: 288085080
• Report Number: 3004209178-2022-03870
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/28/2022 Patient Sequence Number: 1