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

Model Number 8637-20

Device Problem Fluid Leak (1250)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Memory Loss/Impairment (1958); Cognitive Changes (2551)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021, information was received from a patient receiving dilaudid via an implantable pump for non-malignant pain. It was reported that about 3 weeks ago, the patient was hallucinating and "saying things to people that i don't remember" and had a fall. The patient stated that in the fall, they broke their wrist and was put in a cast. The patient stated the pain from their wrist was "almost as bad as my spine at an 8". The patient stated that when they were hospitalized due to hallucinations and fall, "the doctor there and nurses all said the pain pump had leached which was the reason for my hallucinations and all the other wacky stuff i was doing , and they said i had it shut off". The patient also stated that in their hospital paperwork, they wrote that the patient went through withdrawal. The patient stated they were supposed to have a refill on (b)(6) 2021. The doctor, "had it running at 600 or 6,000. Six something. " the patient stated the doctor told them they had enough medication and rescheduled the patient to (b)(6) 2021 for a refill and the patient had to have another psychological approval before the doctor would fill the pump again. The patient stated they were told by their pain management healthcare professional (hcp), the pump was never shut off in the first place as hospital staff said. The patient stated they were afraid to have the pump refilled because they were "afraid it's going to leak again" and they didn't want to go through that again. The patient was redirected to their hcp for further assistance.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12547367
• MDR Text Key: 273799070
• Report Number: 3004209178-2021-14570
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• 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: 09/13/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/29/2021 Patient Sequence Number: 1