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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key11015939
MDR Text Key221706689
Report Number3004209178-2020-21957
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
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
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/24/2013
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: 12/16/2020 Patient Sequence Number: 1
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