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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2022
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving ing dilaudid (hydromorphone) (2 mg/ml at. 355 mg day) via an implantable pump for spinal pain indications. It was reported that the patient presented at the clinic today for a dye study in preparation for pump replacement as it was approaching elective replacement indicator (eri). Needles were seeded in the catheter access port (cap), but no cerebra spinal fluid (csf) was able to be aspirated. Factors that have led to the event were unknown. It was noted that the healthcare provider (hcp) attempted three times to reinsert the needle in the cap and draw back csf. Each attempt resulted in no aspiration of csf through the cap.  it was mentioned that on last two pump refills, on (b)(6) 2021 9. 5 ml was pulled from the pump and 16. 0 ml was expected. On (b)(6) 2021 actual volume was 8 ml and expected was 14 ml.   the issue was not resolved at time of this report, patient status was alive no injury.
 
Manufacturer Narrative
Continuation of concomitant medical products: product id 8780 , serial# (b)(4), implanted: (b)(6) 2015, product type: catheter , ubd: 30-jun-2017, udi#: (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)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14215131
MDR Text Key290474524
Report Number2182207-2022-00699
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
Report Date 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/19/2015
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: 04/26/2022 Patient Sequence Number: 1
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