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

Model Number 8637-20

Device Problem Application Program Problem (2880)

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

Event Date 02/10/2014

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id 8835, serial # (b)(4), product type programmer, patient; product id 8709sc, serial # (b)(4), implanted: (b)(6) 2013, product type catheter.(b)(4).

Event Description

It was reported the personal therapy manager (ptm) was not registering the same dose as what the doctor¿s office was registering by about half a milligram (mg).It was noted the ptm was not saying the same daily dose as what the pump was supposed to be and her "continuous dose was 4.391 and they are showing 4.999 or 4.491 something like that.My bolus dose it was 8.Something but now we just lowered it." it was reported this issue began about a month ago.It was also reported the refill date on the ptm was going back and forth and she had up to six ¿activations¿ a day and if she used on the date will change.It was noted the ptm said one alarm date and when they withdrew the morphine she had 7-8 mg left and it¿s not matching up.The pump was being used to deliver morphine.It was later reported that the patient saw codes ¿8419¿ and ¿8476¿ on the ptm on (b)(6) 2014 but did not know when the motor stall occurred.The reporter stated that this was occurring a couple times a day.It was unknown if the patient was hearing a pump alarm or had magnetic resonance imaging (mri) but the reporter did not think the patient had recently had an mri.The event logs were accessed and reviewed with no motor stalls in the logs back to (b)(6) 2014.The patient had also stated that the ptm was not working at all and would not turn on despite new batteries being utilized.The reporter changed the batteries and the ptm worked fine but the patient was convinced it was not working and needed anew one along with a new pump and catheter.Additional information was received and it was reported that telemetry taken on (b)(6) 2014 had no indication of a motor stall.The patient had continuously experienced trouble with her ptm (personal therapy manager); however, on (b)(6) 2014, it was working appropriately.The logs did show 3 instances where the pa (patient activated) logs indicated a successful pa request (indicated by an 88) followed by an unsuccessful pa request (indicated by an 89) for the same timeframe on (b)(6) 2014.Additional information was received and it was reported that it was never confirmed that a motor stall ever occurred; the logs did not indicate a motor stall occurred.A new ptm (personal therapy manager) was being requested by the hcp (healthcare provider).Additional information received reported that the patient was convinced something was wrong with the ptm, even though it turned on just fine after new batteries were put into it.Patient did not keep the ptm.Additional information later reported the patient¿s ptm does not give the patient all their boluses.Anytime the patient would attempt a bolus the ptm would shut off.The patient gave the ptm for repair.The patient still did not have it back or heard back.The patient wrote a formal letter of complaint about a month or 2 ago.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5104007
• MDR Text Key: 26948082
• Report Number: 3004209178-2015-18701
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• 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: Not provided
• Initial Date FDA Received: 09/25/2015
• Date Device Manufactured: 12/03/2012
• 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 Age: 00031 YR