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

Model Number 8637-20

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problems Complaint, Ill-Defined (2331); Foreign Body In Patient (2687)

Event Date 12/17/2013

Event Type  Injury  

Event Description

It was reported that a health care provider (hcp) reported to the reporter that the patient was in the hcp office on (b)(6) 2013 for a refill, and was complaining of a poking sensation in their abdomen at the pump site.An x-ray was performed and a foreign object was noted.The reporter noted it looked like a needle broke off during a refill.It was also noted the hcp would not disclose any patient information, and just wanted confirmation that the object in the image was not part of the pump.Per the hcp, there was ¿no urgency¿.The drug in the pump was unknown.Additional information has been requested, but was not available as of the date of this report.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_cath, serial# unknown, product type: catheter; product id neu _refillkit_acc, serial# unknown, product type: accessory.(b)(4).

Manufacturer Narrative

Concomitant products: product id: neu_unknown_cath, serial# (b)(4), product type: catheter.Product id: neu_refillkit_acc, product type: accessory.

Event Description

Additional information received reported the patient came to the health care provider (hcp) complaining of pain.The hcp did not think that "whatever it is happened" at the office due to that fact.The x-ray taken was the first done at that office so there was nothing to compare it to in order to find out how the object got there.The pump was being used to deliver morphine 10 milligrams per milliliter at 2 milligrams per day.The start date of therapy was unknown but therapy was considered ongoing.There were no oral medications or allergies as well as no pertinent medical history or medical procedures performed.

• 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 MN 55421 120
• 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: 3575200
• MDR Text Key: 4078336
• Report Number: 3007566237-2014-00170
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• 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: 01/22/2014
• Date Device Manufactured: 10/29/2012
• 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): Other
• Patient Age: 00056 YR