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); Unstable (1667)

Patient Problems Muscular Rigidity (1968); No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 8840, product type: programmer, physician.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving baclofen (500 mcg/ml at 74.92 mcg/day) via an implantable infusion pump.The indication for use was noted as intractable spasticity.It was reported the hcp was having a little difficulty getting telemetry to the pump but was successful.The hcp noticed the pump was a little loose in the pocket and there was a concern that the pump maybe flipped.The hcp had not attempted to access the pump reservoir.The hcp was going to get an x-ray of the pump now to rule out the flipped pump.No symptoms were reported.If additional information is received, a follow-up report will be sent.

Event Description

Additional information received from the healthcare provider reported that the patient experienced increased tightness.The troubleshooting was reported as an x-ray of abdomen to check for pump position and catheter tip position.The x-ray was reviewed immediately.The patient tolerated increase of dose with telemetry, reposition of telemetry and patient in supine on exam table.Per the healthcare provider the cause of the loose pump and the difficulty establishing telemetry was probably position of telemetry upright ie., programmer, for wheelchair, not optimal at the time of the telemetry.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5831229
• MDR Text Key: 50724378
• Report Number: 3004209178-2016-15135
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• 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: 08/04/2016
• Date Device Manufactured: 06/03/2014
• 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: 57 YR