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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Unspecified Infection (1930); Myocardial Infarction (1969); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient receiving dilaudid (dose described to be 4mg at a time) via intrathecal infusion pump for spinal pain.A patient death was reported to have occurred (b)(6) 2020 by the patient's family member.The family member stated ¿the pump killed him.¿ it was reported that the patient had been complaining that something was wrong for ¿about 3 years now¿ and the doctor would just keep pumping him full of dilaudid.The patient went to the hospital about 1.5 weeks ago (around (b)(6) 2020) to have the pump taken out.It was reported that they found the catheter had wrapped around the spine and the whole spinal canal was full of infection.It was stated the patient was coding five times per day.It was reported that the patient had two heart attacks and two strokes in the last three years due to the pump.The patient was sent to rehab after removing the pump without telling anyone where they were sent.The caller stated, ¿my brother just vanished¿ and that the room the patient was in had no phone and no one told the patient where they were.The caller had called the police.It was also stated that the pump drove the patient who tried to kill the pain with anything they could.The caller stated, "my brother is dead from the negligence of the doctor who had only seen the patient two times the whole time he had the pump." additional information was received from the patient's family member.The family member stated the patient's pump was malfunctioning however, the nature of the malfunction was not stated.The family member indicated that over the last 16 months, the patient had a stroke, heart attacks, and was immobilized to a chair because the catheter came out and was wrapped around the spine.It was reported the events that occurred were due to all the infection the patient was having.It was further reported that the patient only saw their managing doctor twice in six years, but they did not have another point of contact.It was then reported that the patient was cremated, and no autopsy was done.

Manufacturer Narrative

Concomitant medical products: product id 8711, serial# (b)(4), implanted: (b)(6) 2007, product type catheter.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11015939
• MDR Text Key: 221706689
• Report Number: 3004209178-2020-21957
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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: 01/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/16/2020
• Date Device Manufactured: 07/24/2013
• 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): Death; Required Intervention; Disability