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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 Problems Electromagnetic Interference (1194); Pumping Stopped (1503); Human-Device Interface Problem (2949); Mechanical Jam (2983)
Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2018
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) regarding a patient who was receiving bupivacaine (2% concentration at 8. 051 mg/day) and dilaudid (4mg/ml at 1. 6101mg/day) via intrathecal drug delivery pump. The indication for use was noted as non-malignant pain and failed back surgery syndrome. It was reported that a motor stall was seen at initial interrogation. The patient recently had an mri. The motor stall was active. The event date was (b)(6) 2018. No symptoms were reported. There were no further complications reported at this time.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the hcp via a manufacturer¿s representative (rep) on 2018-apr-17. The bupivacaine concentration was also reported as 8. 051. It was reported that the patient had a motor stall when working with an engine. The patient stated he was working with a motor/engine that had a magnetic field he was unaware of on (b)(6) 2018 (event date was also reported as (b)(6) 2017, which conflicts with the other information in the event). He heard audible alarms that evening, but stated he didn't know where it was coming from. The patient was seen at the clinic on (b)(6) 2018 and was placed in minimum rate. Troubleshooting consisted of interrogating the pump and reading the logs. The pump was explanted and replaced on (b)(6) 2018. The customer was notified that the pump should be returned to the for analysis, the hospital was in possession of the pump, and it will be returned. The patient weight was provided. The patient status was reported as ¿alive ¿ no injury. ¿ the issue was resolved at the time of the report and the hcp would have no further information on the event. There were no further complications reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated the outcome of the event resolved without sequelae on (b)(4) 2018. The device disposition was unknown. The patient reported a motor stall on (b)(6) 2018, which conflicts with the previously reported information. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related. No further complications were reported/anticipated. Additional information was received from a healthcare provider via a clinical study on 2018-apr-19. It was reported that the event date was (b)(6) 2018 (note: this information conflicts with the previously reported event date(s).
 
Manufacturer Narrative
Analysis of the pump identified corrosion and/or wear and/or lubrication of the motor gear train, and a stall due to shaft bearing. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 12-feb-2020 from the consumer who reported that the patient "had an incident in the last 2 years where the pump was effected by emi from the machine he was working on" stating emi "stopped his pump". The reporter stated it was "horrible event where he went into withdrawal". No further complications were reported regarding the event.
 
Manufacturer Narrative
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)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
MDR Report Key7426394
MDR Text Key105401572
Report Number3004209178-2018-07910
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Notification
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0592-2009

Patient Treatment Data
Date Received: 04/12/2018 Patient Sequence Number: 1
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