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

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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 7724183
• MDR Text Key: 115188560
• Report Number: 3004209178-2018-16770
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 07/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention