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

Model Number 8637-40

Device Problems Filling Problem (1233); Failure to Interrogate (1332); Kinked (1339); Unstable (1667)

Patient Problems Calcium Deposits/Calcification (1758); Granuloma (1876); Overdose (1988); Pain (1994); Scarring (2061); Dysphasia (2195); Complaint, Ill-Defined (2331); Sweating (2444); Ambulation Difficulties (2544); Lethargy (2560); Alteration In Body Temperature (2682)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 8709sc lot# serial# (b)(4) implanted: (b)(6) 2008 explanted: product type catheter.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving morphine dose and concentration not reported via an implantable pump.The indications for use were non-malignant pain and other chronic/intract pain (trunk/limbs).It was reported that in (b)(6) 2016 the patient¿s back pain "went up significantly." the patient had several ct¿s and mri and it was found there was a "calcification on the tip of the catheter." per the reporter they took the patient to surgery where they anchored the pump as it was "flipping" and also took care of the calcification.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 17-feb-2017 from a healthcare professional (hcp).Per the hcp, the patient reported to them that the pump was flipping.The surgeon made a smaller pump pocket and placed extra sutures and anchored the pump to the pocket.The cause of the pump flipping was thought to be that it was an old pocket.The ¿scar¿ at catheter tip was thought to be a granuloma.The surgeon pulled back the catheter tip.With regards to resolution, it was noted ¿pump flipping remains¿ and ¿pulled back catheter tip¿.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the healthcare provider reported that the patient did not have overdose symptoms.The patient was admitted with possible congestive heart failure and acute bronchitis.The patient was put on antibiotics and the symptoms improved.The patient¿s rate for the dilaudid was 5mg/ml at 2mg/day and bupivacaine 2.5mg/ml at 1mg/day.The healthcare provider deceased the rate upon admission to 1.6mg/day dilaudid and 0,5mg/day bupivacaine.The patient also had pa dose 0.199 dilaudid and 0.099 of bupivacaine every 6 hours, 4 in 24 hours.Per the healthcare provider they eventually changed the medication in the pump to infumorph 10mg/ml at 2.99mg/day with a pa dose of 0.2mg every 4 hours with 6 activations in 24hours as per the physician and patient¿s request.No further complications were reported/anticipated.

Manufacturer Narrative

Corrected information: device code (b)(4) and conclusion code no longer applicable.

Event Description

Additional information received reported ever since the current pump has been implanted the patient has had issues.Per the reporter the healthcare provider did surgery on (b)(6) 2016 to address the calcification and re-sutured the pump to keep it from constantly flipping back and forth.The reporter stated that worked for about 4-5 weeks but then the pump started flipping again.The reporter stated "excruciating pain" once the pump started flipping again.The patient has had 3-4 er (emergency room) visits and was admitted to hospital twice due to the pain.The patient and the reporter think the catheter was getting kinked when the pump is twisting.The reporter stated that the nurses have a hard time doing refills and the patient could not get boluses due to turning.The reporter stated they don¿t understand why the managing healthcare provider would not go in and suture the pump again and also stated the managing healthcare provider refused to do anything further.The healthcare provider did change the drug from morphine to dilaudid at ¿1.6¿.The dilaudid was placed the end of (b)(6) 2017 and the patient then experienced several side effect from the dilaudid like sweats, hot then cold, dry mouth which caused an inability to speak and the patient constantly sipping water.When the pump was filled with dilaudid the patient was also given fentanyl patches and nortriptyline.After taking these medications with the dilaudid the pat ient couldn't get up for a day and a half and could only open their eyes for 10-15 seconds.The patient had to be taken back to the hospital because they were overdosed.The reporter requested physician listings.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6335806
• MDR Text Key: 67576988
• Report Number: 3004209178-2017-03995
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: consumer,health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• Date Device Manufactured: 06/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1151-2008
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 86