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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Failure To Service (1563); Device Displays Incorrect Message (2591)

Patient Problems Muscle Spasm(s) (1966); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that, about one month prior to report, the pump went empty and telemetry confirmed that a critical alarm was occurring due to the 0ml reservoir volume.The patient went through withdrawal after the pump went empty, but was doing okay at the time of report.It was also noted that there had been troubles interrogating the pump, but they had been able to read it and the issue resolved.The device system was used to deliver lioresal.Eight days later, it was reported that the patient had presented with bilateral spasticity in the lower extremities and clonic muscle spasms.Per the physician and patient, she had already gone through withdrawals.It was stated that her managing physician would no longer care for her and that is where she ran into the problem.She got to her new doctor just a little too late.The reporter didn¿t think any problem solving had been done because they had known what was wrong.

Manufacturer Narrative

Concomitant products: product id 8709sc, serial # (b)(4), implanted: (b)(6) 2013, product type catheter.(b)(4).

• 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: 3754066
• MDR Text Key: 4481748
• Report Number: 3004209178-2014-07346
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• 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: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2014
• Date Device Manufactured: 11/02/2012
• 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