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

Model Number 8637-40

Device Problems Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Other components include: product id: 8835, serial#: (b)(4), product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding an external infusion device. On (b)(6) 2019, it was reported that the patient was unable to access a bolus via their personal therapy management programmer (ptm). The patient was unable to successfully deliver a bolus. According to the consumer, the patient had just given themselves their first bolus since post op on (b)(6) 2019. The patient reportedly had back surgery which was confirmed to be unrelated to the device or therapy. When requesting the bolus, the patient "got the beep and it flashed the hours glass and then said time remaining 3 hours and 56 minutes". The patient's lockout parameters were provided as follows: the patient can get four boluses and has to wait 4 hours in between boluses. The patient reportedly attempted to give themselves more than one bolus at once, indicative that the patient did receive a bolus and now had to wait out the lockout interval until they could request another bolus. No symptoms were reported. No further complications were reported. On 2019-sep-30, additional information was received from a patient receiving dilaudid (unknown dose and concentration) and another unknown drug via an implantable pump for non-malignant pain. The patient called and reported that they thought their pump was malfunctioning. The patient had back surgery done (previously reported) and was in a rehab center. The patient stated their healthcare professional (hcp) turned off the bolus on saturday ((b)(6) 2019). On sunday, the hcp calibrated the pump and checked the pump programming and adjusted the daily rate to "10%". The patient stated that prior to the hcp coming to see him, he gave himself a bolus. On sunday when the hcp checked the patient's pump with "his ipad, the ipad showed the ptm was not set up". But, the patient said he has the paperwork that showed the ptm was set up with programming. The patient stated the next time he did a bolus, he had 10 hours left and this morning at 6am, he had to wait for a bolus. The patient stated the hcp came this morning ((b)(6) 2019) and checked the pump and "all the boluses are gone". The patient reported their pain has "skyrocket" for the last 12 hours because he was not getting medication. The patient's spouse called again the same date and repeated the previously reported information. The caller noted that the patient had back surgery done 2 weeks ago and the patient was having difficulty with their pain levels. The patient's pain was reported as "out of control". The caller stated that the patient thinks something is wrong with the pump and they want a rep to come check it out.

• 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: 9194575
• MDR Text Key: 170268052
• Report Number: 3004209178-2019-19699
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial