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

Model Number 8637-40

Device Problems Filling Problem (1233); Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Pain (1994); Tachycardia (2095); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving an unknown drug (unknown dose and concentration) via an implantable pump for spinal pain.Beginning on an unknown date, the hcp believed the pump had flipped.Surgery would be scheduled to resolve.The issue was not resolved at the time of this report.The patient's status was alive - no injury.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the catheter (sn: (b)(4) ) found the catheter body was broken.The previously reported conclusion code (b)(4) no longer applies to this event and has been updated to (b)(4).The previously reported method code (b)(4) no longer applies to this event and has been updated to (b)(4).The previously reported result code (b)(4) no longer applies to this event and has been updated to (b)(4): product id 8782 lot# serial# (b)(4) implanted: (b)(4) 2018 explanted: (b)(4) 2018 product type catheter pro duct id 8784 lot# serial# (b)(4) implanted: (b)(4) 2018 explanted: (b)(4) 2018 product type catheter.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

On 2018-july-30, additional information was received from the manufacturer representative (rep).The rep reported the patient did experience symptoms and described them as "patient suspects pump has flipped and is not secure".The pump was suspected to have flipped because "patient reported".The flipped pump was confirmed through fluoroscopy.The cause of the pump flipping was "unknown at this time".Surgery has not been performed and was "not scheduled yet".The event was not resolved.The patient was receiving fentanyl (50 mcg/ml, 50 mcg/day).

Manufacturer Narrative

Section 'device' information refers to the main device.The other relevant component includes: product id: 8784, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter; ubd: 03/29/2019; udi#: (b)(4).Patient code (b)(4) and conclusion code are no longer applicable for this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer via the manufacturing representative (rep) 2018-aug-08.It was reported the patient had experienced a return of pain.It was indicated the healthcare provider was unable to refill the patient's pump because it was flipped.Regarding any environmental/external/patient factors that may have led or contributed to the issue, it was reported the patient was very overweight.It was indicated that to tack the pump to the fascia would make the pump too deep.The pump was interrogated and was still working.It was reported the pump twisted and the catheter snapped to a point approximately 1 centimeter from the end that attaches to the pump.The rest of the catheter could not be found.The catheter looked very tangled under x-ray, and maybe even broken.It was also reported the patient has had major revisions previously for a cerebrospinal fluid leak (please refer to mfr report number 3004209178-2018-04626 for this event) and had an "abandoned lead" somewhere in their spine.The patient became a little tachycardic during the surgery.Therefore, the doctor decided to put the pump back in place disconnected and planned to send the patient to the physician for a major revision.The case was aborted.The issue was not resolved at the time of the report.The patient's status was provided as "alive - no injury." the patient's weight and medical history were unknown.

Manufacturer Narrative

Product id: 8782, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter; product id: 8784, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter; the device codes have been updated to include (b)(4).The patient codes have been updated to include (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On 2018-aug-11, additional clarifying information was received from the manufacturer representative (rep).Clarification for the statement, "pump twisted and cath snapped to a point approx 1cm from the end that attaches to the pump." the reported that the pump flipping and caused the catheter to twist and snap is what "appeared to be what happened".The rep stated, "the piece visible looked like it was pulled and twisted to a point".The rep also clarified that they meant 'catheter' in reference to the abandoned 'lead'.The rep reported that a revision has been scheduled for (b)(6) 2018.On 2018-aug-16, additional information was received from the manufacturer representative (rep).Additional information reported the new spinal and pump segments were placed.The rep stated, "turns out the previous spinal piece though to have been tied off and in the body was actually fully removed previously".The remaining pump segment remains in the patient abdomen disconnected.

• 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: 7731986
• MDR Text Key: 115410956
• Report Number: 3004209178-2018-16935
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• 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): Required Intervention