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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Neurological Deficit/Dysfunction (1982); Loss of consciousness (2418); Test Result (2695)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: healthcare professional (hcp).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient receiving intrathecal baclofen 2000 mcg/ml at 850 mcg/day via an implantable pump.The indication for use was not reported.It was reported that the patient was drowsy and unresponsive on (b)(6) 2018, and the patient was sent to the hospital.The patient was stabilized and felt better on (b)(6) 2018 and (b)(6) 2018.On (b)(6) 2018, the patient was unresponsive again and could not be awoken.The patient lost bladder control and had to be catheterized.The patient was intubated, and her blood pressure was dropping.The hcp accessed the reservoir, and there was no volume discrepancy.There was no pump alarm.The onset of the symptoms was sudden.The hcp was going to program the pump to minimum rate mode.The hcp plan on doing a dye study on (b)(6) 2018 with the neurosurgeon.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative.It was reported the patient had severe dystonia following which her intrathecal baclofen (itb) was increased to 850mcg/day.She was on this dose for 2 weeks.However on (b)(6) 2018-, she became unresponsive and her glasgow coma scale (gcs) was reported to be 5.Her blood pressure was 70mm hg systolic.She remained like this for 12 hours, and then her gcs improved to 14 on its own and 5 hours later again dropped to 6 with hypotension.The hcp reduced the dose of itb from 850 mcg/day to 350 mcg/day following which she improved.She again had similar episodes of low gcs, but this lasted for only 5-6 hours.The patient had another episode last week (from (b)(6) 2018) when her itb was increased to 450 mcg/day.It was noted that ¿usually these episodes follows after a period of severe dystonia for 72-96 hours¿.It was noted that the patient¿s weight was ¿around (b)(6)¿.

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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7735087
• MDR Text Key: 115554182
• Report Number: 3007566237-2018-02269
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/13/2018; 08/08/2018
• Supplement Dates FDA Received: 08/14/2018; 10/03/2018
• Date Device Manufactured: 10/10/2016
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 9 YR