• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
Patient Problems Apnea (1720); Dyspnea (1816); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/10/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709sc; lot#: n110829005; implanted: (b)(6) 2008; product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal bupivacaine 18 mg/ml at 8. 99 mg/day and sufentanil 300 mcg/ml at 150 mcg/day via an implanted pump. It was reported the event/difficulty occurred on (b)(6) 2022 during a procedure. A catheter flow study was performed. The patient had to be administered narcan due to possible overdose of medication during procedure and had difficulty breathing. It was further reported the pump was programmed with bridge bolus on (b)(6) 2022 using preservative free normal saline (pfns) to push out all medication from internal tubing and catheter. It took 23 hours and 17 minutes. At greater than that time, the catheter access port (cap) was accessed, and an aspiration was attempted without success. At that point, the doctor felt comfortable pushing dye through to check for leaks. The doctor was able to follow dye without indication of leaks. He then attended to aspirate again, but this time it was successful. Almost at the end of the procedure, the crna stated that something did not seem right. The patient was not breathing on her own and then they had to start bagging the patient and eventually administered narcan. After the medication was administered, there were indications the patient was breathing on her own. It was unknown if there were any environmental, external, patient factors that may have led or contributed to the issue. Narcan was administered and patient monitored in post anesthesia care unit (pacu). Finally transferred to local hospital for observation. Surgical intervention did not occur and was not planned. It was unknown if the issue was resolved, and the patient¿s status was ¿alive- no injury¿. The patient¿s weight and medical history were asked but unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13772430
MDR Text Key290092840
Report Number3004209178-2022-03318
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 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/21/2014
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: 03/15/2022 Patient Sequence Number: 1
-
-