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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fall (1848); Distress (2329)

Event Type  Death  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was receiving unknown drug, unknown concentration at unknown dose via intrathecal drug delivery pump for non-malignant pain.It was reported that patient death occurred.The consumer had an autopsy.The patient passed away on (b)(6) 2018.The patient fell and had a blunt trauma which was the cause of death.The patient had been buried already.The patient passed in the house.The passing was related to the pump therapy.The patient was told that he could not have medical marijuana and the pump at the same time.The consumer said the stress of being told the pump would be taken out killed him.The patient started leaving the house, eating and feeling better after having medical marijuana.The patient was on medical marijuana and quit smoking and could eat again.The patient had a pump for 22 years.The patient was told he could not have both the pump and medical marijuana at the same time.The caller was patient's cousin.The pump would not be explanted and not be returned.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the hcp was unaware that the patient had passed away until the phone call he received.The hcp reported that the patient's pump was refilled four days prior to the patient's passing and that no changes to the pump were made at all.The hcp further stated that they did not think the patient's passing was related to the pump at all.No further complications were reported.

• 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: 7437178
• MDR Text Key: 105713213
• Report Number: 3004209178-2018-08214
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• 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: 03/19/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 04/19/2018
• Date Device Manufactured: 12/14/2015
• 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 Outcome(s): Death