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

Model Number 8637-40

Device Problems Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); Pumping Stopped (1503); Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)

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

Event Date 12/30/2016

Event Type  Injury  

Event Description

Information was received from a manufacturer representative regarding a patient receiving lioresal (baclofen) 2000mcg/ml for an unknown total dose via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported alarm heard/confirmed by telemetry and a critical alarm was occurring.It was stated that the pump reached elective replacement indicator (eri) on (b)(6) 2016 and showed replace by date of (b)(6) 2017, but also showed that end of service occurred on (b)(6) 2017.Battery performance communication as potential cause was reviewed, and it was explained pump would need to be analyzed to know actual cause.Battery performance information was also sent.It was reported the following actions have already been completed: pump logs were checked.No symptoms were reported.At time of call, manufacturer had not yet contacted the healthcare professional (hcp), so hcp would be best contact depending on the question(s).It was noted that manufacturer representative (rep) found the issue after reading pump post-magnetic resonance imaging (mri).

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(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 the company representative (rep) via return paperwork and the pump logs were provided.The pump was last examined at (b)(6) 2017 (last change (b)(6) 2017) and showed the pump was stopped due to off state.The pump was shut off for 229:42 (h:m).The estimated elective replacement indicator showed 13 months.The logs also included multiple stamps that indicated ¿??/??/????¿ and showed the stopped pump period may exceed tube set message.The logs also indicated the elective replacement indicator (eri) and end of service (eos) had occurred and the active audible alarm was silenced.

Manufacturer Narrative

The other relevant components include: product id: 8709sc, serial# (b)(4), product type: catheter.

Event Description

(b)(4): information was received from a manufacturer representative regarding a patient receiving lioresal ( baclofen) 2000mcg/ml for an unknown total dose via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported alarm heard/confirmed by telemetry and a critical alarm was occurring.It was stated that the pump reached elective replacement indicator (eri) on (b)(6) 2016 and showed replace by date of (b)(6) 2017, but also showed that end of service occurred on (b)(6) 2017.Battery performance communication as potential cause was reviewed, and it was explained pump would need to be analyzed to know actual cause.Battery performance information was also sent.It was reported the following actions have already been completed: pump logs were checked.No symptoms were reported.At time of call, manufacturer had not yet contacted the healthcare professional (hcp), so hcp would be best contact depending on the question(s).It was noted that manufacturer representative (rep) found the issue after reading pump post-magnetic resonance imaging (mri).On 2017-01-30 rp (rep) additional information was received from the company representative (rep) via return paperwork and the pump logs were provided.The pump was last examine date (b)(6) 2017 (last change (b)(6) 2017) and showed the pump was stopped due to off state.The pump was shut off for 229:42 (h:m).The estimated elective replacement indicator showed 13 months.The logs also included multiple stamps that indicated ¿??/??/????¿ and showed the stopped pump period may exceed tube set message.The logs also indicated the elective replacement indicator (eri) and end of service (eos) had occurred and the active audible alarm was silenced.On 2017-03-09 lfc (hcp): additional information received from healthcare professional on 2017-mar-09 reported patient was referred to neurosurgery on (b)(6) 2017 for replacement.It was noted that patient was admitted on (b)(6) 2017 for pump replacement.It was noted the end of service and early replacement indicator alarm had been resolved.It was noted interrogation printouts had been done prior.

Manufacturer Narrative

References the main component of the device system; the other relevant components include: product id: 8709sc, serial# (b)(4), product type: catheter.Analysis of the pump found that there was a voltage related eri or eos with an undetermined cause.Analysis also found there was a low battery reset lab failure with an undetermined cause.Eval code-result updated.Eval code-conclusion still applies.The code will be updated when additional information is received.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.

Manufacturer Narrative

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 received from the healthcare professional on april 27, 2017.The patient's weight at the time of the event was provided as (b)(6) kg.No further complications were reported/anticipated.

Manufacturer Narrative

Correction - (b)(4).Conclusion code has been updated.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code 1 because, although the device meets design specification, corrective actions are focused on enhancements to the design making this the closest code available with respect to this event.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.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected information: no eval explain code if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Corrected information: no eval explain code.If information is provided in the future, a supplemental report will be issued.

• 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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6282645
• MDR Text Key: 65963582
• Report Number: 3004209178-2017-01883
• 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,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/02/2017

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: 07/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 05/02/2017; 05/02/2017; 05/02/2017
• Supplement Dates FDA Received: 02/17/2017; 03/10/2017; 04/14/2017; 04/28/2017; 05/02/2017; 09/29/2017; 09/29/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2011
• 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-3043-2011, Z-2276-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 75