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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 Fluid/Blood Leak (1250); Pumping Stopped (1503)
Patient Problems Diarrhea (1811); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Pain (1994); Skin Discoloration (2074); Therapeutic Response, Decreased (2271); Therapeutic Response, Increased (2272); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Underdose (2542)
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 consumer regarding a patient who was receiving bupivacaine and dilaudid (unknown concentration and dose) via an implantable pump. Indication for use was non-malignant pain. The date of the event was unknown. It was reported the pump was leaking inside of the patient since 5-6 months ago. There was a bluish black color below the pump. The patient had heart and breathing problems 3 months ago which the patient believed was related to the pump. The patient¿s blood pressure was very high, ¿over 200¿ and was related to the pain he was having. The pump went bad in (b)(6) 2018 and was beeping every 10 minutes. The patient experienced pain that had increased "extremely high". The patient could feel that he was not getting medication. Two weeks prior the pump stalled completely. The patient had "dt shakes" and withdrawals. On (b)(6) 2018 the patient had an appointment with the doctor and it was verified the pump had stalled. The doctor tried to refill the pump although the pump was stalled. After filling the pump, it was beeping. On (b)(6) 2018, the patient was admitted to the hospital because everything he ate went straight through him. The patient had diarrhea for 16 days. An implant was planned for next week monday or tuesday. The surgery was cancelled on (b)(6) 2018. The patient was being discharged from the hospital on (b)(6) 2018. No further complications were reported.
 
Manufacturer Narrative
Device code (b)(4) no longer applies to the event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative (confirmed via healthcare provider) indicated the patient was originally at a hospital to replace the pump. The patient and family were threatening to sue the hospital and report them to medicare for reasons unrelated to the pump issues. The hospital then elected to not perform the surgery and referred the patient to another facility. The managing physician was unable to change the pump at their usual hospital, because they no longer wanted to support medtronic pump cases at their facility. The managing physician was trying to get privileges at another hospital, but it was taking longer than expected. Another physician at a different facility eventually successfully replaced the pump without issue on 2018-(b)(6). Per the managing physician, the pump had stalled "due to old age" and was not leaking into the patient. The pump had only stalled once and needed to be replaced due to regular end of life. The patient symptoms were resolved and the patient was fine now. The pump would not be returned for analysis. No further information was available at this time.
 
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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 Key7860239
MDR Text Key119690928
Report Number3004209178-2018-20222
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,consum
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/26/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 09/10/2018 Patient Sequence Number: 1
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