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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Unstable (1667)

Patient Problems Fall (1848); Pain (1994); Seroma (2069); Swelling (2091)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving fentanyl 60 mcg/ml; 15.006 mcg/day via an implanted pump.The indication for pump use was non-malignant pain.It was reported that the patient fell six days after implant.The patient experienced a sudden change in therapy/symptoms with pain in the "butt cheek".Since implant in (b)(6) 2016, the patient had swelling at the pump site.The patient went in for a refill (b)(6) 2016 and the hcp (healthcare professional) drew fluid out of the pump pocket area and the swelling did go down, but it was back on (b)(6) 2016.The patient had a lot of excess skin due to losing 200 pounds.The pump was loose from the back.The patient rolled over and the pain pump got hung up on the bed.When the patient would sit the pump would point outward.It would take a long time for the personal therapy manager (ptm) to sync.The patient would have to use her hand to keep the pump flat when she sat down.The pump was revised on (b)(6) 2016.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.The patient had swelling in her right leg since pump implant.The swelling so bad the patient had to go to the emergency room.Computerized tomography (ct) scan was done.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the hcp reported he assumed the cause of the pump movement was due to an anchor that became un-anchored and the patient¿s anatomy.The pump sticking out and snagging had been resolved by the revision.The cause of the slow ptm sync was unknown.The hcp stated the ptm ¿was sync was done asap¿.

Manufacturer Narrative

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

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5949310
• MDR Text Key: 54668890
• Report Number: 3004209178-2016-18871
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• 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: 01/10/2017
• Date Device Manufactured: 03/28/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR