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

MAUDE Adverse Event Report: MDT 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
 

MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Patient Problems Low Blood Pressure/ Hypotension (1914); Muscular Rigidity (1968); Cognitive Changes (2551); No Code Available (3191)
Event Date 09/30/2017
Event Type  Injury  
Manufacturer Narrative
"eyes rolling back in her head".A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for intractable spasticity and multiple sclerosis.The pump contained gablofen [2000 mcg/ml] at a dose of 651 mcg/day.It was reported an alarm was heard and confirmed by telemetry.The representative stated the patient was due for a pump replacement, and the pump hit early replacement indicator (eri) on (b)(6) 2017.The schedule to replace by date was (b)(6) 2017.The representative stated that the hcp tried to interrogate the pump on (b)(6) 2017, and it said the pump was in safe state.They ¿couldn't do anything or move on the screen¿.The representative stated the patient was hallucinating, super spastic, eyes rolling back in her head, blood pressure was dropping, and they were sending the patient to the emergency room.It was further reported the patient was seen in the hcps office on (b)(6) 2017 with increased spasticity, decreased blood pressure, and hallucinations.A pump interrogation showed the pump was in safe state since (b)(6) 2017.The dosing had gone from 651 mcg/day down to 12 mcg/day.An ambulance was called, and the patient was transferred to the emergency room.Troubleshooting/diagnostics included checking the pump logs.The patient was admitted to the intensive care unit (icu) on (b)(6) 2017 and was being medically managed until the pump could be replaced on (b)(6) 2017.It was unknown if the issue was resolved at the time of the report.The patient status at the time of the report was alive ¿ no injury.No further patient complications were reported.
 
Manufacturer Narrative
Updated to reflect the information received on (b)(6) 2017.Updated to reflect the receipt of the pump on (b)(6) 2017.Updated to reflect the report that analysis has not yet been completed on this pump.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider on (b)(6) 2017.It was reported that the patient had a pump check on (b)(6) 2017, another pump check for (b)(6) 2017.It was assumed that the medical symptoms were resolved unless anything new showed up as the patient was coming in for pump checks.No further complications were reported.
 
Manufacturer Narrative
Updated to reflect the information received on (b)(6)2017.Device codes (b)(4) added to reflect the information received on (b)(6)2017 if information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on (b)(6)2017 from the patient's healthcare provider via the manufacturer's representative.It was confirmed that there was a low battery reset message in the pump logs in addition to the safe state message.The patient's eri alarm was confirmed to be normal.Per the hcp, the pump was confirmed to have been replaced on (b)(6)2017.No further complications were reported.
 
Manufacturer Narrative
Analysis found high resistance in the pump battery.If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNCHROMED II
Type of Device
PUMP, 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6947807
MDR Text Key89290134
Report Number3004209178-2017-21762
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 Physician
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/14/2012
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2017
Initial Date FDA Received10/13/2017
Supplement Dates Manufacturer Received10/13/2017
11/01/2017
12/06/2017
Supplement Dates FDA Received10/16/2017
11/01/2017
12/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age57 YR
-
-