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

Model Number 8637-20

Device Problems Filling Problem (1233); Difficult to Interrogate (1331); Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received from the consumer regarding a patient receiving intrathecal fentanyl.The dose, concentration, and lot number were unknown.The indication for use was non-malignant pain.The patient found out her pump was half flipped over and was informed (b)(6) 2016.The patient was not scheduled for surgery yet, but she had been approved for the surgery.They could barely get the medicine in, and if it totally flipped, they would not be able to refill it at all.The first health care provider (hcp) the patient saw said it was loose and "did not say anything." the second hcp the patient saw recommended that patient get the pump repositioned by sewing it back in and doing an analysis on the pump.It was hard for the patient to get her boluses with her personal therapy manager (ptm) sometimes since (b)(6) 2015 because the pump was partially flipped.The ptm worked without the detachable antenna, but the patient still thought the communication issues were due to the pump being partially flipped.The patient was working with her hcp to schedule a surgery to address the partially flipped pump and sew it back in and do an analysis.Patient symptoms, troubleshooting performed, the cause of the flipped pump, and the outcome were unknown.Follow up was conducted.If additional information becomes available, the event will be updated.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from a consumer.The patient had moved from id to ca and was seeing a new healthcare provider (hcp).She had told one of the nurse practitioners (np)that her device was "sticking out" but nothing was done.At her next visit, the np that she saw that time told her that her device was "halfway flipped".Further information was not provided.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; 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: 5510401
• MDR Text Key: 40669431
• Report Number: 3004209178-2016-04893
• 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
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2016
• Date Device Manufactured: 10/04/2013
• 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): Required Intervention
• Patient Age: 00056 YR