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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)

Patient Problems Hematoma (1884); Irritation (1941); Pain (1994); Dizziness (2194)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

Other relevant components include: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2017 explanted: product type catheter.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 health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for intractable spasticity.The pump contained lioresal [500 mcg/ml] at a dose of 35 mcg/day.It was reported the patient complained of being lightheaded, woozy, and having severe sub-scapular pain during post-operation on (b)(6) 2017.The hcps spoke to the patient and had her decrease her oral baclofen in half and contacted the representative to confirm that the patient was on 35 mcg/day of intrathecal lioresal.The hcps sent the patient to the emergency room (er) to be evaluated for her scapular pain as it might have been due to irritation of the catheter being placed mid-thoracic.There were no diagnostics or troubleshooting performed.There were no environmental/external/patient factors that might have led or contributed to the issue.The patient sent to er to have pain addressed and oral baclofen was cut in half.It was unknown if the issue was resolved at the time of the report.No surgical intervention occurred, and it was unknown if surgical intervention was planned.The patient weight was unknown.The patient status at the time of the report was alive ¿ no injury.No further patient complications were reported.Additional information was received from a healthcare professional (hcp) via a manufacturer's representative (rep).It was reported that a motor stall was seen at the initial interrogation of the pump.The patient recently had a magnetic resonance imaging (mri) scan.The mri was done due to a suspected problem with the device/therapy.It was reported a hematoma occurred during the pump implant.It was reported the patient developed a hematoma at the distal end of the catheter during the pump/catheter implant surgery and was at a rehab facility because of it.The patient had 2 motor stalls due to mri.The first was on (b)(6) 2017 at 18:14 that recovered the same day at 20:45.The second occurred on (b)(6) 201718:37 with no recovery per the event logs and the pump is audibly alarming.The pump was programmed to minimum rate mode.It was reported the hematoma began on (b)(6) 2017 and was diagnosed on (b)(6) 2017.No further complications were anticipated/reported.

Manufacturer Narrative

Update: the previously applied device code (b)(4) is no longer applicable.

Event Description

Additional information was received via a healthcare provider.Regarding actions / interventions taken to resolve the motor stall, it was noted that a company representative tried to restart but was unable.The motor stall and hematoma had resolved.

Manufacturer Narrative

Conclusion code was added.Conclusion code applies to the pump and conclusion code applies to the catheter.

Manufacturer Narrative

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

Event Description

Additional information received on 2017-jun-22 from the hcp reported they had not seen the patient since implantation.They recommended following up with the surgeon/surgeons.It was unknown if the motor stall and hematoma had been resolved.

Manufacturer Narrative

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): 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: 6612369
• MDR Text Key: 76687049
• Report Number: 3004209178-2017-11643
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• 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: 06/29/2017
• Date Device Manufactured: 03/28/2017
• 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-0591-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR