MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problems Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 01/01/2017

Event Type  malfunction  

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

Information was received from a consumer regarding a patient implanted with a neurostimulator (ins) for obsessive compulsive disorder.It was reported that the patient had been having trouble recharging for about six weeks prior to this report.It was reported that the patient was getting poor coupling.The day before this report, the patient had no bars, then got 2 or 4, and finally got all bars, but it took a long time to get full coupling.It was reported that it takes even longer to recharge the device now.The patient did not have their programmer at the time of this report, so no troubleshooting was performed.It was noted the patient would check the implant to confirm it was on.There was no indication of patient harm.A replacement recharging antenna was sent to the patient to see if that resolved the patient¿s recharging issues.No further complications were reported.

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.It was reported that the patient's healthcare professional (hcp) hadn't seen the patient since implant.It was noted that the hcp would have a manufacturer representative (rep) contact the patient.It was also noted that it may be time to replace the patient's battery.The rep reported that they were not sure if the patient's recharging issue was resolved.It was also unclear if the recharging or reduced battery capacity is the issue.

Event Description

Follow up information received from the patient reported that they were sent a new antenna to resolve their issues with recharging, poor coupling, and taking longer than usual to recharge.It was noted that the issues have resolved, but they are still problematic.The patient stated that it was "perhaps" the old antenna malfunctioned, causing the issues, but they are unsure.No further complications are anticipated.

Manufacturer Narrative

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

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6380771
• MDR Text Key: 69166865
• Report Number: 3007566237-2017-00866
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2017
• 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 Age: 52 YR