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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Premature Elective Replacement Indicator (1483)

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

Event Date 12/19/2016

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 2000 mcg/ml gablofen at a dose of 1100 mcg/day via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported that an alarm was not heard, but confirmed by telemetry.The pump showed an elective replacement indicator (eri) of 13 months in (b)(6) 2016 and showed eri occurred on (b)(6) 2016.The pump logs were checked and no symptoms were reported.Additional information was received on (b)(6) 2017.The patient or others did not hear an alarm.The cause of the premature eri was not determined.The actions and interventions taken were: the hcp consulted with a manufacturer technician, the pump was refilled and no discrepancy was noted in stated and actual reservoir volume, and a referral was made for pump replacement.

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6300765
• MDR Text Key: 66491346
• Report Number: 3004209178-2017-02515
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: 01/12/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR