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U.S. Department of Health and Human Services

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

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MEDTRONIC 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); Improper or Incorrect Procedure or Method (2017); Device Ingredient or Reagent Problem (2910)
Patient Problems Scar Tissue (2060); Seroma (2069); Dizziness (2194); Fluid Discharge (2686); Convulsion/Seizure (4406); Alteration in Body Temperature (4568)
Event Date 04/21/2022
Event Type  Injury  
Event Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient who was receiving hydromorphone (10 mg/ml at 3. 8 mg/day) via an implantable pump for non-malignant pain. It was reported that the patient had a pump refill done on thursday ((b)(6) 2022) by a (b)(6) nurse. When the nurse accessed the pump they got back an "orange, clearish" solution from the pump initially. They then restarted and pulled back 4 ml of clear drug from the reservoir. The nurse stated that they thought they had gone through some sort of seroma that could have caused the discolored solution. They then put 10 ml of saline in and removed that amount from the pump reservoir to ensure the needle was properly placed and proceeded to fill the pump with 40 ml of drug. After removing the needle there was "some drainage about the size of a dime" from the needle insertion. The nurse put a band-aid over it and the patient was "acting normal" after this and was perfectly fine. Later in the day a family member took the patient to the emergency room (er) "feeling dizzy and hot and lost his appetite. " the patient was discharged later the same night. They then went back to the er the following day and they tried to give him narcan; the patient went into "a small amount of convulsions" after being given narcan and was then given a few different drugs, fentanyl and a few others. The patient was transferred to the icu where he remains. The healthcare providers (hcp)s "felt confident this isn't due to the pump" but they would like to do a pump reservoir volume check and catheter dye study. The patient was "stable, coherent and talking. " they will provide any additional info as it becomes available.
 
Manufacturer Narrative
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)
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 Key14246258
MDR Text Key290569494
Report Number3004209178-2022-05428
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2018
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: 04/28/2022 Patient Sequence Number: 1
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