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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Application Program Problem (2880); Inappropriate or Unexpected Reset (2959); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: neu_unknown_cath, product type: catheter.Product id: 8840, product type: programmer, physician.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

Information was received from a foreign healthcare provider (hcp) via a distributor regarding a patient who was receiving gabalon via an implantable pump for an unknown indication for use.The distributor received the complaint from a healthcare provider on 2017-apr-03, indicating that a pump alarm occurred.The issue was first discovered by the patient or a family member.A representative of the distributor visited the home of the patient, and confirmed that a two-tone alarm rang every hour.The error codes 01 (reset) and 18 (event status cleared) showed on the screen of the programmer.It was stated that ¿those error codes were not including no action required errors.¿ it was noted that some data [such as eri (elective replacement indicator)] was confirmed to be missing.A comment from the customer stated ¿opinion view on the causal relationship between the pump and the electric stimulation therapy [this was interpreted as there might be a relationship between the pump issues and stimulation therapy].It was stated the ¿pump has been used normally but the patient received an electric stimulation therapy before/after the event.¿ there were no reported symptoms.No complications were reported.

Manufacturer Narrative

It was previously reported that the last name of the initial reporter was healthcare professional.However, it should have been reported as (b)(6).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.It was further reported there were no additional interventions taken to resolve the alarm/pump reset besides the re-programming that was already reported.No further information was reported on whether the event has been resolved or not.The pump has not been explanted as it is still in use.It was reported that the serial number of the programmer is not known.The patient¿s gender, weight, and date of birth are not known.The implant date of the device was not known.Further information was requested regarding the electric stimulation therapy that had been reported and no additional information was provided.There were no reported complications.

Event Description

On 2017-may-26, additional information was received from a foreign healthcare professional (hcp) and manufacturer representative (rep) via (b)(4).Information reported the alarm activation was reported on (b)(6).No hcp, including the physician had yet to confirm the alarm themselves, but the physician was explaining that the patient's family had reported occasional beeping sounds every hour.There was no change/issues with the patient's condition noted.Since there was not enough time for the rep to explain to the physician how to use the n'vision programmer at this time, the rep was to follow-up on the issue via email as instructed by the physician.Later on (specific time not provided), the rep asked the physician to check the "clinicians' ifu" and then call the rep back.However, the rep did not hear from the physician.Therefore, the rep visited the physician on (b)(6).At this time, nobody had yet confirmed the alarm being activated except for the patient's family.The rep visited the patient and family in the ward with the physician.Reportedly, a two-tone alarm had been activated every hour at 7:55, 8:55 and 9:55 on that day, too.Interrogation using an n'vision programmer was attempted but the tool kit could not be opened and thus the a supervisor was contacted for instructions.Although the patient's information (i.E.Catheter information) was saved, data such as drug dosage were black (concentration was saved) and thus the drug amount was temporarily entered as "15 ml" for the time being.The daily dose as entered as "24 mcg" based on the amount dosed at the previous refill session.The amount for alarm setting was also black and it was entered at this time.It was revealed that the critical alarm was set at 1 hour and corrected to 10 minutes then updated.The tool kit was opened and the event logs were checked, "01 (dated on (b)(6) at 21:00) and an unknown code 18 (dated on the day, (b)(6)) were shown there".The rep inquired if anything had occurred on (b)(6).The physician reported that on that date, the patient had received electromagnetic stimulation.The physician did not go into the date further, but the physician claimed that the patient had reported the activation of alarm around that date, but was "not perfectly sure".The physician also commented that "it just have been fine for the patient to undergo electromagnetic stimulation if mri was also allowed for patients with the device".Later on (specific time not provided), the rep asked the physician for the aforementioned episode outside the ward where the patient was not present.However, the physician still did not check the exact date of it.The rep asked the physician not to conduct electromagnetic stimulation since the contributing/causal factor was not clearly known.The physician agreed.The rep checked the summary and confirmed that elective replacement indicator (eri) was indicated as 81 months.At 13:00, the rep visited the patient's ward again with the physician and the family confirmed no alarm was activated by then.Past 14:00, the family confirmed no alarm.The rep asked the family to notify the physician or a nurse immediately if an alarm was activated.

• 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: 6554150
• MDR Text Key: 74773925
• Report Number: 3004209178-2017-09927
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Date Device Manufactured: 05/17/2016
• 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