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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Contamination (1120); Patient-Device Incompatibility (2682); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Priming Problem (4040)
Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pain (1994); Respiratory Distress (2045); Weight Changes (2607)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_cath, lot/serial#: unknown, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device. The drug being delivered was not reported. The reason for use was non-malignant pain. It was reported that the patient has an infected pump and it was unknown if the infection was related to the device. There were no other symptoms reported. The patient has lost 25 pounds over the past year. The rep stated that the physician plans to "wash the pump and put it somewhere else". The hcp is going to cut the catheter then rinse the pump with saline with antibiotic and put it in the back. The rep called back in and stated that they removed 47. 8 cm of the original 8780 catheter that was implanted. The original length was 78. 2 cm. The catheter was pulled out in pieces when the pump was moved from the pocket in the abdomen to a pocket in the low back. The doctor was not able to retrieve the catheter connector with collet due to scar tissue build up. The doctor was to decide if they will subtract anything from the catheter since the connector, and maybe a small portion of catheter, could not be retrieved. The rep wanted to review the catheter length as the trimmed more than he calculated earlier. Original length was 106. 1 cm, and then 12. 5, 12. 3, and 23. 0 cm were removed or ~47. 8 cm so ~58. 3 cm left. A new 8784 was used and ~45. 2 cm removed so ~28. 5 cm left added to the 58. 3 old section for a new length of ~86. 8 cm or ~0. 190 cm. It was reviewed that would be the amount to prime as the entire catheter was cleared through the catheter access port (cap). Physician may want to prime less as they think some catheter remained and they couldn't find part of the catheter with the connector on it. It was also reviewed there is some dead space in the cap - above 0. 06 ml's - so if they only primed the catheter the whole system still wouldn't be primed but they could do less if they want to. The patient's dose is 0. 75 mg/day at 1 mg/ml - reviewed that the pump is moving fairly fast so even if they don't fill the catheter completely it would catch up quickly. Calculated about 6 hours for catheter volume to clear even with no prime. The patient was having respiratory issues (surgery had just concluded and patient was still under anesthesia) and he thought a cardiac arrest which he then clarified was more of a respiratory issue and bp issue (bp bottomed out) while i was on the phone with him. He clarified to staff that patient was not getting any drug from the pump at this point. By the end of the call the patient was awake and doing better. There were no further complications reported/anticipated.
 
Manufacturer Narrative
Corrected information. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep on 2018-aug-08. It was unknown when the infection was first noticed and the cause of the infection was not determined. The infection was ¿healing. ¿ the cause of the respiratory issue and blood pressure issue was unknown, but it was not related to the therapy. The serial number of the catheter was provided. There were no further complications reported/anticipated.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7724183
MDR Text Key115188560
Report Number3004209178-2018-16770
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
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/24/2017
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: 07/26/2018 Patient Sequence Number: 1
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