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); Difficult to Advance (2920); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, lot# / serial# : (b)(4) , implanted: (b)(6) 2010, product type: catheter ; product id :8598a , lot#/ /serial#: (b)(4) , implanted: (b)(6) 2011, product type: catheter. 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 dilaudid and bupivacaine via an implanted pump. The indication for pump use was spinal pain. The patient reported, "i suspect there is something wrong with my pump and i keep getting the bums the rush on this pump - return of symptoms and volume discrepancy". He stated, ¿either the battery is low and is not functioning correctly or something". Per the patient, in (b)(6) 2021 he had a really bad fall and first started going through withdrawals and it was getting worse since then and every time they did the pump refill they were taking out more medication than they were expecting. When they expected to get 5 cc they were taking out 10 cc. When they expected to take out 3 cc they were taking out 6 cc. About 3 months ago they did a catheter dye study and said everything was fine. He stated that he was told that there wasn't enough wrong for the insurance to pay for a revision. He also stated that another doctor wanted to do a back fusion of 5 of his vertebrae, so they did an mri. Per the patient, the mri noted, "signal at the distal end of the catheter, probably caused by old (blank) the last word is not there¿. The ordering physician of the mri said to have his pump managing physician call them, but when he spoke to his pump managing physician¿s office, they told him they could not use that mri because they didn't order it. He did obtain a copy of the mri and provided a copy to his pump managing physician¿s office. Last week, he had a myelogram done for the potential back fusion which was unrelated to his infusion system or therapy and they were going to look at t12 which was where the catheter was. He stated that he had not yet gotten the results of the myelogram. The patient was redirected to his healthcare provider to further address the issue.

Manufacturer Narrative

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

Event Description

Additional information received from a company representative (rep) reported that the cause for the inability to aspirate the catheter was not determined with certainty. It was also reported that the cause for the new spinal segment catheter curling downward during implant was not determined; just kept turning downward. Additional information received from a company representative (rep) reported that the patient felt the pump was under-dosing. A possible catheter occlusion was noted.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12335874
• MDR Text Key: 267044164
• Report Number: 3004209178-2021-12553
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/18/2021 Patient Sequence Number: 1