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

Model Number 8637-40

Device Problem Pumping Stopped (1503)

Patient Problems Diarrhea (1811); Dyspnea (1816); Hemorrhage/Bleeding (1888); Pain (1994); Rash (2033); Scar Tissue (2060); Weakness (2145); Sneezing (2251); Therapeutic Response, Decreased (2271); Ulcer (2274); Anxiety (2328); Distress (2329); Complaint, Ill-Defined (2331); Malaise (2359); Irritability (2421); Ambulation Difficulties (2544); Cognitive Changes (2551); Weight Changes (2607); No Code Available (3191)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) and consumer via a company representative regarding a patient with an implantable pump for degenerative disc disease and spinal pain.The pump administered bupivacaine with concentration 2 mg/ml at a dose rate of 2.04 mg/day and morphine with concentration 5 mg/ml at a dose rate of 5.1 mg/day.It was reported that the patient had magnetic resonance imaging (mri) on (b)(6) 2019 and they were trying to reprogram the pump today ((b)(6) 2019).The hcp noted a service code 100 for motor stall when interrogating the pump.It had not been less than 2 hours since the patient exited the mri.The pump logs were read and showed multiple motor stalls and recoveries since (b)(6) 2019 with pump currently stalled since earlier this morning.It was further noted that the patient mentioned that her personal therapy manager (ptm) also showed a code of 8476 regarding stall.The option to program the pump to a minimum rate and manage the patient with meds outside of the pump, until pump could be replaced, was being considered.Additional information was later received via a consumer on 2020-jan-03.The patient was described as being 57 years old and physically disabled with chronic spinal pain disease.It was noted that 15 years ago (prior to the pump) the patient had an accident/injury where while on the operating table the patient ¿died and took multiple blood to resuscitate¿.It was further noted that the patient later developed mrsa from this procedure at the hospital.The patient also had a second spinal surgery and it was noted that the patient was blessed to walk, but a physician had gone in after and cleaned up mistakes of the first surgeon and sewed up.It was indicated that the patient had cages and screws in her ribs and back.The patient was currently angry and was in very chronic pain.The pump was alarming.The patient knew her pump and she heard a critical pump alarm.The pump was noted as having malfunctioned.It was noted that a physician and intern had called a company representative on (b)(6) 2019 and they worked for 3 hours, but was unable to restart the pump.The physician tried to drain and refill the pump even though a refill was not due until (b)(6) 2019; this did not resolve the issue.Regarding the pump not working, withdrawal had started right away.It was noted that they overheard a company representative say the pump was bad/not working, should be removed and sent back for analysis, and that the physician should prescribe oral morphine to the patient.The patient was upset and thought their physician should have got her in an ambulance to the hospital to remove the pump right away and did not.The physician did not prescribe and only wrote a normal script.The patient had been so sick, and their physician thought maybe it was a touch of the flu.Withdrawal symptoms reported.The patient had been having serious morphine withdrawals for 10 days now.The patient experienced weight loss, rash, scabs, sores over her body even ear lobes.It was further noted that the patient had never seen such massive diarrhea.It was indicated that the patient ate a box of imodium; the patient had not eaten any food in a week/10 days, the patient couldn¿t brush their teeth or stand up.The patient had blood coming out nose.It was stated that the patient looked like death warmed over and if the patient had a gun, she would have killed herself last week.The change in therapy/symptoms had occurred suddenly.The patient was anxious and having anxiety related to the alarm event and anticipation of removal surgery, further noted that it was rough.The patient couldn¿t breathe because of panic attacks and withdrawal.Prior to (b)(6) 2019, the patient weight was approximately (b)(6) pounds, but had lost 30 pounds in 5 days.The patient¿s current weight was (b)(6) pounds.The physician had called the patient a day before or after christmas.The patient was weak and had (inaudible) sneezes and was losing it with anger.The hcp had offered to mail a prescription to the patient to be delivered (b)(6) 2020.On (b)(6) 2020 an official had called to confirm the patient address to then mail a prescription.The patient had mentioned to their physician that she had a rash before but didn¿t know when, no allegation of it being with the pump.It was noted that the physician called the patient a couple days later and the patient was still having diarrhea and soars/scabs.It was indicated that the hcp may refer the patient to another physician for pump removal.The patient also had a small prescription of norco (twice per day) that was noted as being like tylenol to the patient, and nucynta that helped along with the pump usually.The patient couldn¿t not get a nucynta prescription because the pharmacy was out, then it was christmas, and then the patient was in withdrawal.The patient was currently on norco and nucynta.No surgery was currently scheduled.It was further noted that the patient decided that even though she likes the pump, when it reaches end of service (eos) in (b)(6) 2021, she would choose not to replace it because of her age and upkeep or replacing the pump every 6 years or so.It was also noted that if the patient does not get the pump replaced, she would probably end up in a wheel chair.No further patient complications have been reported as a result of this event.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9566202
• MDR Text Key: 190203363
• Report Number: 3004209178-2020-00518
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/08/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2019
• Initial Date FDA Received: 01/08/2020
• Date Device Manufactured: 06/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 77