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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Failure To Service (1563); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Nausea (1970); Overdose (1988); Seizures (2063); Urinary Retention (2119); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Numbness (2415); Sweating (2444); Shaking/Tremors (2515); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Alteration In Body Temperature (2682); No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2016

Event Type  Injury  

Event Description

Information was received from a healthcare provider via a manufacturer representative on 2017-jun-07 regarding a patient receiving morphine (20mg/ml at an unknown dose) via an implanted infusion pump.The indication for use was non-malignant pain.Other medications the patient was using at the time of the event included bupivacaine.It was reported that the pump was interrogated at an unknown date by the patient's managing physician, and premature battery depletion was found.The pump reportedly lasted approximately 3 years.The pump was replaced with no harm to the patient, and the situation was considered resolved.There were no environmental, external, or patient factors that were thought to have led to the issue.The patient's status at the time of report was alive - no injury, and no further complications were reported or anticipated.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative on 2017-jun-07.It was reported that the pump performance /early battery depletion was in question.It was indicated that the reason for removal was prophylactic replacement to avoid in-vivo battery depletion.The device was used in the patient and was intended for treatment.There was no patient death related to the event.It was indicated that no patient injury occurred, and the patient recovered without sequela.There were no rotor or dye studies performed.No further complications were reported/anticipated as a result of the event.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the pump found wear on the motor o-ring for gear number three.Eval code - conclusion code ¿ 11 is being updated to 71 for this event.Eval code - result code 3233 is no longer applicable.Device code (b)(4) was updated to (b)(4).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.

Manufacturer Narrative

(b)(4) no longer apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer on 2017-nov-10.It was reported that the patient was not sure of their weight at the time of the event, but it was noted that there was no significant weight loss or weight gain.It was noted that the rescheduled visits were on (b)(6) 2016 (rescheduled for (b)(6) 2016), (b)(6) 2017 (rescheduled for (b)(6) 2017), (b)(6) 2017 (pump was alarming and patient was rescheduled for (b)(6) 2017).The only symptoms the patient experienced were related to the refill on (b)(6) 2017, when the patient's right leg gave out, the patient experienced numbness in the abdomen and back, and could not urinate.The numbness and right leg giving out reportedly went away about 30 minutes later, but it was noted that it happened maybe 2 more times after the pump was refilled.The patient reportedly ended up with a urinary tract infection and was treated by the primary care physician on (b)(6) 2017 with an antibiotics and a prescription to help her urinate.It was further noted that the reason the patient could not urinate was because the pump was giving the patient more medication than called for and was malfunctioning.The patient was reportedly told that there was a mistake by a nurse who got the patient's name mixed up with another patient by the same name, so the patient's medication wasn't in for the refill on (b)(6) 2017.To resolve the rescheduled refills, it was noted that the patient just had to wait until the next visit, but the doctor did fire an employee for not telling her the patient called regarding the inability to urinate.Additionally, the nurse was no longer ordering the patient's medications.The patient was reportedly told that the doctor was ordering the medications now.The patient reportedly ended up going to the emergency room on (b)(6) 2017 after she started to get sick with withdrawals, but was not due for a refill until (b)(6) 2017.On (b)(6) 2017, the patient went to the hcp's office and the pump said she had about 12-14 days left, so the hcp upped the patient's medication by 8%.The patient reportedly experienced no relief.The patient went back on (b)(6) 2017 to have the pump filled, and it was empty.The pump was then filled.The patient went back on (b)(6) 2017 because she was having symptoms again, including numbness in legs, falling, inability to urinate, upset stomach, and shakiness.The patient felt horrible and her whole body was just not right.The hcp didn't know how much medication the patient was getting so it was decreased by 28%.The patient was also reportedly taking medication to help her urinate.The patient went back to the hcp on (b)(6) 2017 with the same symptoms, and the pump was decreased by an additional 23% due to the pump giving out more medication than it should.The hcp was reportedly calling another hcp to schedule the patient for surgery to replace the pump.The pump was replaced on (b)(6) 2017, and the patient was referred to a new pain management hcp.It was further noted that the patient went through so much suffering, and if the patient's original hcp had ordered the medication on time to begin with and refilled the pump on time (which should have been (b)(6) 2017), the patient's would not have gone through all this agony (note: this conflicts with the previous report that the pump was replaced due to premature battery depletion).The patient was reportedly still so sick, and just started feeling better this week (relative to (b)(6) 2017).**additional review determined that the information previously reported in manufacturer report # 3004209178-2017-17975 [medication spilling over], report # 3004209178-2017-09557 [missed refill], and report # 3004209178-2017-09361 [past missed refills] now applies to this event.Additional information regarding these events will continue to be reported under this manufacturer report, which pertains to the following information: [missed refills/pump medication spilling over/battery depletion/replacement].**.

• 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: 6629529
• MDR Text Key: 77242841
• Report Number: 3004209178-2017-12437
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR