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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Application Program Problem (2880); Protective Measures Problem (3015); Insufficient Information (3190)

Patient Problems Pain (1994); Seizures (2063); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Distress (2329); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

Other components include: product id: 8835, serial#: (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving hydromorphone 35% mg/ml for a total dose of 11.3 mg/day via an implantable pump for non-malignant pain.It was reported that the personal therapy manager (ptm) was indicating the patient was locked out from receiving a bolus.The patient wanted to know how long they needed to keep the ptm on pump when requesting a bolus.The patient reported being unable to successful deliver a bolus.The patient noted sometimes when they request a bolus that they will get locked out for 30 minutes.The patient stated their boluses have to be at least 30 minutes apart.The patient stated that it will be two hours since last bolus, and they will get a lock out for 30 minutes.It was reviewed what uplink error was.No symptoms were reported.The event date was (b)(6) 2019.No further complications were reported/anticipated.Additional information was received from a patient regarding the 8835 personal therapy manager (ptm) used with an implantable drug infusion device.The drug being delivered was 35 mg/ml hydromorphone at 13.962 mg/day.It was also reported that the current dosing was 1.348 mg (40.344 mg/day) with a previous dosing of 1.209 (13.789 mg/day).The reason for use was non-malignant pain.It was reported that the ptm is indicating the patient is locked out from receiving a bolus.The caller reported being unable to successfully deliver a bolus.The issue started ¿about 7 months ago¿ prior to the call date of (b)(6) 2019.They reported numerous ptm screens, ¿some with a funny asterisks or triangle, some saying lockout for 30 min, some with an x.¿ this had been ongoing and the last month had been the worst.They were in pain due to not being able to deliver a bolus and ¿feeling like he's detoxing'', especially in the past month.At his last refill, on (b)(6) 2019, ¿the doctor pulled 20 ml out or 40 out of the pump due to unsuccessful activations.¿ the printout showed 110 unsuccessful activations.Actions taken prior to the call consisted of the patient speaking with the healthcare professional (hcp) and manufacturer¿s representative (rep), and the patient was told to call the manufacturer to replace the ptm.The patient reported that he informed the rep on the ptm issues 3 times, the first being in (b)(6) 2018.During the call, it was reviewed with the caller about the replacement option and noted that any lockouts would be related to pump programming and if any lockout issues persist with replacement ptm then pump programming may need to be reviewed with the hcp.The caller was transferred to the repair department.There were no further complications reported/anticipated.Additional information was received from a consumer on 2019-may-13.It was reported that the patient experienced withdrawal like symptoms "like last month''.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient on (b)(6) 2019.The patient reported the pump inside them was defective.The patient stated they were upset and they have experienced a lot of health and neurological issues, which included three seizures.The patient stated the unit inside them was not responding.The patient reported they need to have a brand new unit put in them and they were very upset because they have not been getting their medication through the pump.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), product type: catheter; product id: 8780, serial# (b)(4), product type: catheter; product id: 8835, serial# (b)(4), product type, programmer, patient.The pump was returned, and analysis no anomalies.The catheter was returned, and analysis found damage to the transition tube.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer who reported that he thinks that the ptm isn't giving him a bolus when it says it is because he has had neurological seizures this month.The patient thinks there is an issue with the pump.The patient stated his dose/concentration in the pump was a lot because "probably the pump wasn't working".The patient stated he was frustrated because he's had issues with his pump since he got it.Per the patient his drug dose was high due to his tolerance, his dose wasn¿t where he wanted it.The patient also stated that he used to have baclofen in pump but no longer does, he has to take the baclofen in pills because it wasn't working and now it is working.If he didn't take oral meds, he would be screwed.The also reported that his pump was alarming last month and the ptm ¿dinged¿ to show him that the pump was alarming as well.The patient¿s healthcare provider addressed the alarm and was no longer alarming.No further complications were reported regarding the event.

• 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: 8616633
• MDR Text Key: 145292916
• Report Number: 3004209178-2019-09721
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2020

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: 01/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 06/04/2019; 02/26/2020
• Supplement Dates FDA Received: 05/17/2019; 06/06/2019; 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• 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): Other
• Patient Age: 55 YR