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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 8637-20
Device Problems Kinked (1339); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
Information references the main component of the system. Other relevant device(s) are: product id: 8731, serial# (b)(4), implanted: (b)(6) 2004, product type: catheter; ubd: (b)(6) 2006, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturing representative (rep) regarding a patient receiving 500 mcg/ml of baclofen at 28. 58 mcg/day via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease. It was reported a catheter issue had occurred. The patient was having a routine pump replacement and the catheter ¿wasn't flowing,¿ so the healthcare provider decided to revise the spinal segment. The issue was diagnosed during the revision. Technical services confirmed the new catheter length/volume and confirmed the priming bolus information. No symptoms were reported. It was reported the event occurred on (b)(6) 2018. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturing representative (rep) on may 03, 2018. The rep reported the issue was discovered during the surgery when the patient's pump was being replaced. The rep and the physician discovered the catheter was not flow ing and then went to revise the catheter. The physician went into the spinal segment of the catheter and noticed the catheter was kinked. The physician was not able to get cerebrospinal fluid (csf) back. The physician took out the spinal segment, and when the physician gently tried to pull the catheter back, only half of the catheter came out. The surgical tech measured the segment that was removed, which was roughly 13 centimeters (cms), which indicated half of the catheter was still in the spine. It was reported there was no harm to the patient during this process, and the rep stated the patient was doing fine, to their knowledge.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturing representative (rep) on may 07, 2018. Regarding the broken catheter, the rep thought the catheter broke when the doctor pulled on it, but they could not be sure. The rep confirmed the remaining segment was out of use, and a new segment was implanted. The portion of the catheter that was removed was thrown away by the surgical technician and the rep was unable to return the segment.
 
Manufacturer Narrative
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) 2018. The patient's weight was provided as (b)(6) kilograms.
 
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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 Key7481738
MDR Text Key107187349
Report Number3004209178-2018-09939
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
Type of Report Initial,Followup,Followup,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2012
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received05/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/28/2010
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: 05/02/2018 Patient Sequence Number: 1
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