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

Model Number 8637-40

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dyspnea (1816); Fatigue (1849); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Therapeutic Response, Decreased (2271); Irritability (2421); Sweating (2444); Ambulation Difficulties (2544)

Event Date 05/01/2017

Event Type  Injury  

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 was received from a healthcare provider (hcp).It was reported that there was a change in therapy effect.They wanted to okay the mri since the pump has been nothing but trouble since the pump was replaced.The mri was to figure out what has gone on with him recently and what went on with him recently leading up to (b)(6) 2017.When they got home the patient had spent basically the entire day in bed and when he finally did, he sat in his wheel chair and was sitting there drowsy, almost asleep.The patient hadn't shaved, eaten, taken his medicine, or showered or dressed and she got home she was trying to speak to hear but appeared to be falling asleep and drowsy.It was stated that the patient became combative when she tried to get him to get dressed and go to the doctors.The last couple of weeks the patient had been okay and after the replacement, appeared to be having withdrawals and he went into extra rigidity and throwing up, spasms shortness of breath.It appeared at first that he was not getting enough medication and was given oral baclofen until the managing physician could get to the surgeon and find out what the dose of what was put back in the pump.The oral medication made him completely nauseas and was throwing up green vile.For the past few months they have been going back to the doctor and getting dose changes.The blood work was normal and a dye study was done with no problems found.His medication was increased on (b)(6) and he was taken off his oral baclofen.The patient was okay for a while and then he started having rigidity and has been on nausea and reflex medications since and his legs still have rigidity and spasms.These symptoms were considered sudden.

Manufacturer Narrative

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

Event Description

Additional information received from an hcp reported a dye study was done by neurosurgery, and there were no issues.X-rays were done, and the pump was in good position.Actions/interventions taken to resolve the withdrawal symptoms included oral baclofen and ondansetron prn (when necessary).The withdrawal symptoms were intermittent.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).A dye study was performed by neurosurgery and the patient was given oral baclofen.

• 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: 6814820
• MDR Text Key: 83456347
• Report Number: 3004209178-2017-18007
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Date Device Manufactured: 03/03/2017
• 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 Outcome(s): Other
• Patient Age: 69 YR