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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Output Problem (3005); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, lot/serial#: (b)(4), implanted: (b)(6) 2017, product type; catheter, ubd: 31-jul-2019, udi#: (b)(4).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 bupivacaine and morphine at unknown concentrations and dosages via an implantable infusion pump.The indication for use was noted to be non-malignant pain.It was reported that the patient's pump was implanted on (b)(6) 2017 and the pump was working in the beginning but then it stopped helping the patient's pain.This was discussed with the patient's health care provider (hcp) and they ended up doing a revision surgery "maybe 3 months ago" and had to "repair the pump" because they "found it wasn't working¿ they had to re-route it or something".They didn't think the surgery worked because it was "still not working".The caller didn't know any other details of the issue.The caller was redirected to follow up with the hcp to discuss concerns.They noted they were going to the hcp's office the next day to have "some tests done".No further complications were reported.

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 a consumer on 2019-jul-01.It was reported that when the pump was replaced in (b)(6) 2018 or (b)(6) 2018 and the drug was increased (note: this conflicts with the previous report that the pump/catheter were revised rather than a pump replacement), it was found that none of the drug was going to the spine and it was going to the tissue.Since the replacement, the patient's pain was still uncontrollable.When asked to clarify whether the pump or catheter was replaced, the reporter confirmed they thought it was the pump.The patient had stage 3 kidney disease since (b)(6) 2018 and diabetes, and the kidney hcp said a lot of the increase in the disease was because the other hcp told the patient to take aleve, motrin, etc.In the beginning it wasn't so bad, but over time it had gotten worse.Additional information was received via a consumer and also a friend/family member of the patient.The patient was diabetic, and their diabetes had damaged their nerves which was the reason the pump was implanted.The patient¿s diabetes was confirmed as pre-existing and that the patient has had it for 20 years.The patient still had his hip pain that began three months after the implant surgery.The date of the event was unknown.When standing up for 20 minutes, the patient had to sit down on one side to get some relief.The patient wanted a second opinion on his pump due to his pain.Physician listings were provided as requested.It was noted that the pump had moved during the first implant surgery and that a second surgery was required.It was indicated that it was possible that it¿s been a year.The date of event was unknown.Regarding the date of the event, it was noted that the physician would know.The patient was told that they had used a sonogram or a ¿special machine¿.The secondary caller (friend/family member) indicated at the time of the report that the patient¿s catheter was replaced, but that it didn't move.Regarding the medication that was in the pump at that time, it was indicated as being morphine that was normally sent in a tube.The previous and current concentration and dose rate of morphine was unknown.It was further reported that they were calling to find out the success rate of the patient¿s morphine shots that he was getting every month and half or two months for the past five to seven months.Regarding if these were actual shots or refills, it was clarified that they were shots.The healthcare provider would give the patient small amounts of morphine shots because of blood pressure.The reporter was redirected to the healthcare provider to discuss drug related questions / concerns.

• 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: 7742870
• MDR Text Key: 115817779
• Report Number: 3004209178-2018-17250
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2019

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: 12/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 07/01/2019
• Supplement Dates FDA Received: 10/04/2018; 07/16/2019
• Date Device Manufactured: 07/03/2017
• 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
• Patient Age: 72 YR