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

Model Number 8637-40

Device Problems Filling Problem (1233); Use of Device Problem (1670); Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591); Application Program Problem (2880); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 06/03/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id 8835, serial # (b)(4), product type programmer, patient; product id 8780, serial # (b)(4), implanted: (b)(6) 2014, product type catheter.(b)(4).

Event Description

On (b)(6) 2015 when the patient turned the ptm (personal therapy manager) on, it would turn off.The patient was using sunbeam super heavy duty batteries in the ptm.The patient obtained new batteries and the ptm worked; this resolved the issue.The patient also reported that the ptm was showing 4 hours after he requested a bolus and that was his full lockout time.The patient didn¿t feel like he didn¿t get the bolus because there was no increase in pain.He didn¿t think that he was getting the dose because the ptm refill date kept moving out.The device system was delivering morphine, on (b)(6) 2015, clonidine was added to the pump, and then the clonidine was removed from the pump some time prior to (b)(6) 2015.As of (b)(6) 2015, the patient was still having concerns regarding his therapy, but was working with his doctor or representative.His next appointment was (b)(6) 2015.The patient reported that the low reservoir alarm was set for 1 ml.The patient thought the drug was being wasted over the past two refills because the health care provider (hcp) did not understand the personal therapy manager (ptm) dose restriction interval (dri).He patient said that they expected to take out 2.2 ml, and more than 6.5 ml was removed.The patient said the health care provider (hcp) felt that the drug removed was within specifications.The patient also reported that a bolus was unexpectedly declined, and the patient was locked out.This happened twice in a row on (b)(6) 2015.¿every couple of days¿ the patient would get locked out for 4 hours when he believed he should be able to receive a bolus.The patient activated dose was 5mg with an interval of 4 hours.The dri was (b)(6).The patient¿s max was 6.The simple continuous dose was 0.2mg/hour, and they believed that could ¿still stay programmed the way it was now.¿ the patient hada pump refill coming up on (b)(6) 2015.The patient verbally described their lock out parameters, and they did not understand the lock out parameters.The patient reported his pain level ¿got very bad¿ two weeks ago (from (b)(6) 2015).The onset was sudden.For six months, things were good.The patient would utilize his over 6mg/day max and take some ibuprofen with a pain level of 0-1.But then the following day it would get worse where he would use up all of his intrathecal (it) drug and have to take ibuprofen ¿like candy.¿ the patient ¿did not really need¿ the boluses at night.On (b)(6) 2015, the health care provider (hcp) gave him a programmed bolus via the 8840, and then the patient was locked out for 8 hours with the ptm.The patient was wondering if something ¿got messed up¿ with the programming.The patient wanted to understand ¿the clock.¿ he wanted to ask for lockouts 8x/day, 1/60m, 2x/3h.The patient stated right now it was set up at 6x/day, 1x/4h, 6x/24h, and he wanted more flexibility.The system was initially reported to be delivering morphine at a concentration of 10 mg/ml and a dose of 8.749 mg per day, but it was later reported that and clonidine at a concentration of 500ug/ml with a max dose of 307.38ug.The lot numbers was unknown.Indications for use were non-malignant pain and other non-malignant pain.Additional information has been requested regarding interventions and the patient¿s outcome, but was not available as of the time of this report.If additional information becomes available, the event will be updated.

Manufacturer Narrative

Patient code (b)(4) device codes (b)(4).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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5079774
• MDR Text Key: 26249990
• Report Number: 3004209178-2015-18013
• Device Sequence Number: 1
• Product Code: LKK
• 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,consum
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• 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: 08/29/2017
• Date Device Manufactured: 01/28/2014
• 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 Age: 00058 YR