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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Failure To Service (1563); Device Displays Incorrect Message (2591)

Patient Problems Itching Sensation (1943); Vomiting (2144); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 06/09/2016

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient who was receiving morphine at an unknown dose and concentration via an implantable pump for non-malignant pain.It was reported that the patient just had her pump replaced on (b)(6) 2015 due to longevity and was due for a refill at the end of (b)(6) 2016.It was stated that the patient's pump had been out of morphine for almost two months and it was currently alarming and the patient needed to find a healthcare provider (hcp).The patient started hearing a dual alarm on (b)(6) 2016 and went to an emergency room for withdrawal symptoms where they gave the patient a shot of morphine.It was noted the sound was consistent with the pump alarms.The patient was scheduled for a refill on (b)(6) 2016, but the hcp rescheduled the appointment because the doctor was out of the office.The rescheduled date was (b)(6) 2016.On (b)(6) 2016, the patient learned her medical insurance had changed and they could not refill the patient's pump due to insurance reasons.The patient went to a new hcp on (b)(6) 2016, however that office could not read the patient's pump with the clinician programmer.The patient was sent to another location on (b)(6) 2016 and the hcp was again unable to read the pump using a different clinician programmer.The pump was still alarming and they were unable to refill the pump.The patient's withdrawal symptoms were clarified to be itching, felt like bugs were crawling on the patient, felt like the patient was going to die, vomiting, unable to eat or drink, and could hardly lift her head off the bed.The symptoms came on gradually, but got worse and worse.

Event Description

Additional information was received from a consumer.The patient left ¿(b)(6),¿ and their pump went dry.They went to a health care provider (hcp) on (b)(6) 2016, and they were unable to read it.They went to a 2nd office, and they could not read it.The pump still alarmed and still had not been read.The pump had not been refilled.The pump was dry, and the patient¿s symptoms were the same.They were getting a burning feeling in their stomach, under the pump.They were still sick and ¿needed a doctor that knew about the pump to fix it.¿.

Manufacturer Narrative

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5844278
• MDR Text Key: 51115346
• Report Number: 3004209178-2016-15490
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2016

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: 04/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided; 08/19/2016
• Supplement Dates FDA Received: 09/13/2016; 09/24/2017
• Date Device Manufactured: 10/20/2015
• 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: 51 YR