MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7427

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturing representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for lumbar radiculopathy.Information was reported that when the patient's stimulation is turned off and then gets turned back on it feels like the stimulation is stronger and then starts to drop off.The caller stated that the patient was programmed with pw: 450 us rate 60 hz 0+ 2- amp: 0.7 v.Electrode impedances: 01 452 02 452 03 690 12 452 13 690 23 453 the caller read from the report that showed the patient had access to control rate 25-115 hz amp: 0 - 4.40 v pulse width: 210-450 us.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information: it was reported the cause of the stimulation output issues was not determined.As discussed with tech services the rep tried to turn up with the clinician programmer and the same issue (patient could feel strong stimulation then it would diminish).The rep also tried different electrodes combinations with the same results.The issue has not been resolved, but they are planning to discuss about replacement with the patient.No further information was reported.

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7151364
• MDR Text Key: 96230872
• Report Number: 3004209178-2017-26725
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2008
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2017
• Date Device Manufactured: 07/12/2007
• 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