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

Model Number 8637-20

Device Problem Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Overdose (1988); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sedation (2368); Coma (2417)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient regarding their implantable drug infusion device.The drug being delivered was baclofen (unknown) at 425 mcg/day with an unknown concentration.It was noted that the dosage was adjusted every 3 months.The reason for use was intractable spasticity.It was reported that ¿the pump hasn't worked right since it was implanted" ((b)(6) 2018).The caller reports she went to the er/hospital on (b)(6) 2019 for overdose and she wants to know where she can go for a dye study test.She was breathing 6 breaths per minute and went to comatose for 15 hours.The patient has had a rotor study done and an injection test/needle test.They also took an x-ray.Back in (b)(6) 2018 they took an x-ray and everything looked like it was placed good.The caller stated, ¿just because you do an x-ray doesn't mean it was working properly,¿ and they wanted to have the dye study test done so she doesn¿t have another overdose and "almost die." there was no out of box failure reported and there was no medical/therapy problem related to a small components product.The patient was redirected to follow up with a healthcare professional (hcp) to discuss symptoms.The patient stated that she is upset that the managing hcp is not returning her calls since (b)(6) 2018 and her implanting surgeon refuses to do a dye study t est.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the hcp on 2019-jan-30.The hcp stated that they ¿believe the patient is sensitive to increasing the dose.She is not getting the best spasticity relief, but when dose is increase she gets sedated.I fell she just doesn¿t tolerate it well.The pump is not malfunctioning.¿ symptoms associated with the overdose included sedation and decrease in breathing to 6 per minute.The cause of the overdose was not determined.Actions taken to resolve the issue included the patient being in the hospital with supportive care and the dose was decreased.The overdose has been resolved.The patient weight was reported.There were no further complications reported/anticipated.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8257488
• MDR Text Key: 133378054
• Report Number: 3004209178-2019-01209
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• Date Device Manufactured: 02/15/2018
• 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
• Patient Age: 20 YR
• Patient Weight: 64