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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359); No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 8709, serial# (b)(4), implanted: (b)(6) 2003, product type: catheter.Product id: 8709, serial/lot #: (b)(4), ubd: 16-jul-2005, 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 who was receiving morphine, bupivacaine, and an unknown drug at unknown doses and concentrations via intrathecal drug delivery pump.The indication for use was noted as spinal pain.It was reported that the patient's pump had moved and was "resting on top of my leg." there was "no reason why in 2 years this has moved." the pump had moved since implant, on (b)(6) 2016.After the pump was implanted, the healthcare provider (hcp) at the time told the patient the pump was going to move right away and told the patient to put a belt around the pump to beep it inplace.The patient thought the catheter had now moved starting in (b)(6) 2018 and was causing her "all kinds of problems and pain." per the patient, the hcp would no longer see the patient because she had missed 3 appointments.The pump was due to be filled next month, relative to 2018-jun-26 and she had no hcp.She was also currently sick, not feeling well, and had high blood pressure.The hcp had sent the patient's paperwork to another hcp, who would look at the patient paperwork and decide if he would take the patient, but the patient was unsure if the process would take place in a month when the patient was due to be filled as the hcp was in office on wednesdays.The patient was previously told that someone needed to turn the pump off prior to the pump running empty because it could damage the catheter.There were no further complications reported at this time.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that they had an appointment scheduled at the end of (b)(6) 2018 to have the pump filled and would ask if the catheter really has moved or if it was something else.The patient repeated that she knew the pump moved back and forth and would know move after the appointment.There were no further complications reported at this time.

• 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: 7651604
• MDR Text Key: 113191261
• Report Number: 3004209178-2018-14696
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• 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: 06/26/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 07/25/2018
• Date Device Manufactured: 08/12/2016
• 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: 66 YR