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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 Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Complaint, Ill-Defined (2331); Sedation (2368); Loss of consciousness (2418)
Event Date 03/13/2018
Event Type  Injury  
Manufacturer Narrative
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 manufacturer representative regarding a patient who was receiving ga blofen (2000mg/ml at an unknown dose) via intrathecal drug delivery pump. The indication for use was noted as intractable spasticity. It was reported that the patient went in for a normal refill on (b)(6) 2018. There was a pocket fill and it appeared that 35ml of drug was filled into the subcutaneous tissue. The manufacturer representative was not sure if a manufacturer kit was used for the refill. The patient went to the intensive care unit (icu) the night of (b)(6) 2018. The patient was recovering from the event as of (b)(6) 2018. They were being monitored. There were no further complications reported at this time.
 
Manufacturer Narrative
Patient code (b)(4) no longer applies. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a hcp. It was reported that the patient had become unresponsive during the event. She was intubated and sedated for 3 days. She remained hospitalized for a week while her dose was adjusted after her pump was refilled. There were no further complications reported at this time.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7342133
MDR Text Key102510351
Report Number3004209178-2018-05097
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 company representative,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1060-2011

Patient Treatment Data
Date Received: 03/15/2018 Patient Sequence Number: 1
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