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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Inadequacy of Device Shape and/or Size (1583); Unstable (1667)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: product id 8780, serial # (b)(4), implanted: (b)(6) 2015, product type catheter.(b)(4).

Event Description

The patient and patient's healthcare professional (hcp) via the patient reported a "very vague" complaint about the pump placement and a medical event.The patient stated their pump was "more of an oval shape" and that the pump would move and it did not feel that the pump was in the place it was supposed to be.The patient talked to their hcp and they reported the pump was in the right place.The patient also stated that the nurse said that something was not reading right and the monitor was not reading what it was supposed to (clarification attempted but was unsuccessful).The patient was then sent home after "they put medicine in" (pump refill) and they went to bed.The next morning, the hcps realized "they had a problem" and attempted to contact the patient while the patient was "laying in bed, dying." the patient was being treated for malignant pain with morphine (unknown) at an unknown dose and concentration.The outcome of the event was not reported.Additional information has been requested, but was not available as of the date of this report.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4993210
• MDR Text Key: 24571012
• Report Number: 3004209178-2015-15820
• 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: company representative,health
• Reporter Occupation: Other
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2015
• Date Device Manufactured: 05/23/2015
• 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: 00067 YR