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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 15-mar-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a company representative regarding a patient who was receiving dilaudid with concentration 10 mg/ml at a dose rate of 2.996 mg/day via an implantable pump for non-malignant pain.The patient¿s medical history included spinal stenosis of the lumbar region.It was reported that the patient has not received good pain relief since implant ((b)(6) 2017).The patient¿s managing pain physician aspirated 20 ml from pump during refill 1 month ago.At a previous refill it was 19 ml.It was further indicated that the pump flipped when the patient went in for the first refill after implant and the physician could manually flip/ manipulate pump.The patient did not remember specific dates; the date of the event/difficulty was unknown.The managing pain physician recommended the patient to an alternate physician for evaluation.A dye study was performed today ((b)(6) 2018) and the physician could not aspirate cerebral spinal fluid (csf).It was further noted that the catheter tip appeared to be at c7 and the catheter was away from spine at lower thoracic area with the use of fluoro.The physician scheduled a revision and was to contact a manufacturer representative with the date/time; representative updated.Surgical intervention did not occur and was not scheduled, but was planned.The issue was not resolved at the time of the report.The patient was without injury at the time of the report.Other medications the patient was taking at the time of the event was unable to be obtained.Regarding any environmental/external/patient factors that may have led or contributed to the issue, it was noted that there were no contributing factors.No further patient complications have been reported as a result of this event.The patient¿s medical history included: spinal stenosis of lumbar region.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a company representative.Regarding the volume discrepancy at the first refill, the company representative was informed by the physician¿s office that the first pump refill occurred on (b)(6) 2017.They had not been updated on a surgery date as of yet, moreover, the patient was scheduled to have a follow-up appointment with the physician concerning the dye study and plans on (b)(6) 2018.The company representative attempted to contact the alternate physician¿s office and had not yet been able to speak with someone.It was further noted that at the time of the dye study, the physician stated that he felt the pump needed to be anchored again and a catheter revision needed to be scheduled.The physician indicated they would contact the company representative/manufacturer when planned.The primary company representative was also updated.The patient continues to use the pump as ordered and was waiting for the revision, otherwise there was no additional information available at this time.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer¿s representative (rep) on (b)(6) 2018.It was reported that the device would not be returned because the hospital disposed of it.The information was confirmed with the physician/account.There were no further complications reported/anticipated.

Manufacturer Narrative

Product id: 8781, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a company representative.It was indicated that a pump replacement was performed on (b)(6) 2018.A company representative had assisted the physician with the procedure.Additional information was also later received from a healthcare provider via an alternate company representative on (b)(6) 2018.The cause of the pump having flipped, catheter having moved away from the spine, and volume discrepancy at refills was indicated as not having been determined.It was however noted that the patient was obese and had a lot of loose skin.The pump having flipped, volume discrepancy at refills, and catheter having moved away from the spine had been resolved.Both the pump and catheter were replaced on (b)(6) 2019.Regarding the patient¿s outcome, it was described that the patient seemed to be doing fine.

• 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: 7494505
• MDR Text Key: 107599210
• Report Number: 3004209178-2018-10348
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• 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: 05/07/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 05/07/2018; 05/25/2018; 05/29/2018
• Supplement Dates FDA Received: 05/08/2018; 05/29/2018; 05/30/2018
• Date Device Manufactured: 07/26/2017
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 77