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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problems Abdominal Pain (1685); Seizures (2063); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider on 2017-nov-07. It was reported that the patient was admitted to the hospital in early october with signs and symptoms of drug withdrawal. The patient was transferred to another hospital and was scanned showing a pump stall, per the nurse who phoned the managing hcp's office. The patient was ordered oral narcotics. The reported symptoms included withdrawal symptoms, seizure/tremors, and abdominal pain. It was noted that at the time of report (2017 (b)(6)), the patient was presently hospitalized for pneumonia and sepsis, and needed to be cleared of infection prior to replacement.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via manufacture representative on (b)(6) 2017 regarding a patient receiving clonidine (350mcg/ml at 17. 49mcg/day), bupivacaine (2mg/ml at 0. 0999mg/day), and dilaudid (10mg/ml at 0. 5mg/day) via an implanted infusion pump. The indication for use was intractable spasticity. It was reported that an alarm was heard or confirmed by telemetry, but there was no mention of an audible alarm. During a refill, the hcp happened to notice that the event logs indicated a low battery reset and safe state had occurred. There were no events showing up in the event logs prior to (b)(6) 2017, and the date of the event was unknown. It was noted that the elective replacement indicator (eri) had 8 months left on the pump, and the patient was being supplemented with oral meds. It was unknown if the patient experienced any symptoms.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key6987206
MDR Text Key103300972
Report Number3004209178-2017-22756
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 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2012
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 Received11/07/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/29/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2276-2009, Z-3043-2011

Patient Treatment Data
Date Received: 10/30/2017 Patient Sequence Number: 1
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