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

Model Number 8637-20

Device Problems Device Alarm System (1012); Migration or Expulsion of Device (1395); Failure To Service (1563); Unstable (1667); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Therapeutic Response, Decreased (2271)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received on (b)(6) 2017 from a health care provider (hcp) regarding a patient with an implantable drug infusion pump indicated for spinal pain.The pump contained bupivacaine [3 mg/ml] at a dose of 0.6683 mg/day and dilaudid [2 mg/ml] at a dose of 0.4455 mg/day.It was reported there was a suspected flipped pump.The hcp stated that the patient told him the last time they filled the pump ((b)(6) 2017), it was flipped.The hcp was ¿was holding it up to make it perpendicular¿, so they could access the pump to fill it.The patient had an anteroposterior (ap) view x-ray which confirmed that the pump was not flipped at that time.The hcp stated the pump was empty, and interrogation showed 20.1 ml dispensed since update.The hcp stated the patient was experiencing ¿worsening abdominal pain¿ which was the reason she had the pump.The hcp also stated that the patient had gastroenteritis.The hcp stated they would be unable to fill the pump that day due to the (b)(6).The hcp stated that he would likely program to the pump to minimum rate.The hcp stated that the patient had not heard the pump alarm despite it reaching a low reservoir and empty reservoir status.Additional information received from another hcp on (b)(6) 2017 reported an alarm was heard and confirmed by telemetry.An empty pump alarm was occurring.The patient missed a refill.The hcp stated they planned on refilling the pump at the hospital and then discharging the patient to her managing hcp for follow-up.The hcp stated the patient had withdrawal symptoms.The change in therapy/symptoms was considered sudden.The hcp stated the pump could have been empty for a couple days.The hcp believed there was 0 ml left in the pump that day.The hcp did not have the complete details in front of him at the time of the call.The hcp found out from the managing hcp that the pump was not flipped, but was sitting in an ¿abnormal situation¿ due to the patient losing weight.The hcp stated he would be doing the refill under fluoroscopy because of the situation.No further patient complications were reported.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative on 2018-(b)(4).The manufacturer's representative (rep) was at the facility with the patient on the date of the report, as the patient was having a pump refill with sedation.It was reported that the patient's pump is tipped/tilted in the pocket and that is why there are issues with pump/8840 communications and possibly the patient's personal therapy manager (ptm) and pump, along with having to manipulate the pump in the pocket and having the patient be sedated to perform the pump refill.It was reported that the pump was being revised on 2018-(b)(4).No further complications were reported.

Manufacturer Narrative

The ¿intervention required¿ box should no longer be checked as surgical intervention did not occur and is currently not planned.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on (b)(6) 2018 and it was reported that the pump would not be removed.The issue with the patient¿s ptm (personal therapy manager) was solved with further patient education.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer.The patient reported they believed their pump was deep inside their body and stated they have had three revisions because they have lost weight.The last revision occurred in (b)(6) 2018 because the patient¿s spinal cord stimulation device (scs) was replaced at this time and the doctor decided to revise the pump while they were replacing the scs battery.The patient reiterated that the revision was due to weight loss.The patient stated that every time she went for a refill they had to sedate her because it was so painful to put the medication in.It was unknown when the first two revisions occurred due to the weight loss.

• 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: 7059483
• MDR Text Key: 92940439
• Report Number: 3004209178-2017-24352
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 07/05/2018; 07/25/2018; 08/08/2018; 08/08/2018; 04/11/2019
• Supplement Dates FDA Received: 07/09/2018; 07/30/2018; 10/03/2018; 10/04/2018; 04/12/2019
• Date Device Manufactured: 03/29/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 79