MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 37714

Device Problems Failure to Deliver Energy (1211); Device Difficult to Program or Calibrate (1496); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 03/31/2017

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient's ins was only getting 5-7 days out of a full charge and that it takes a long time to charge.The patient stated that it takes almost all day to charge and that they sometimes get 8 coupling bars and sometimes 0.It was noted that the coupling was very sensitive and that the patient could loose coupling by moving the antenna over 1 inch.An x-ray of the ins showed no issues with ins/leads and the patient mentioned that they had not increased program parameters recently.It was also reported that the patient was unable to program adaptive stimulation for different positions with the patient programmer.The patient had already tried troubleshooting on their own.The patient's hcp advised the patient to request a manufacture representative to be present at the surgery to replace the patient's ins.Follow-up was conducted to obtain more information regarding the upcoming surgery.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer on 2017-08-16 reporting that the implant had been checked by a manufacturer re presentative in the past who said that everything was okay.After that appointment, the patient no longer felt stimulation as they had always felt it before.The patient preferred feeling stimulation because now they could not tell if it was working.The lack of s stimulation sensation started about a month to 6 weeks ago in (b)(6)2017.The patient had no problem adjusting stimulation by themselves.It was reported that there was poor coupling as the patient was getting 0 coupling bars.Prior to the call, the patient had repositioned the antenna and used the antenna dial however troubleshooting could not be done on the call since the caller did not have the implantable neurostimulator recharger (insr) or patient programmer available.The recharging issues started on (b)(6)2017 additional information was received from the consumer on 2017-08-17 when they had their equipment available.An antenna locate (al) feature was attempted with a result of 60.When the patient tried to initiate charge they were seeing zero boxes shaded.A new recharger antenna was requested and sent.No further complications were reported.

Manufacturer Narrative

Corrected information: sex, date of birth if information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 6565104
• MDR Text Key: 75087990
• Report Number: 3004209178-2017-10239
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2017
• Date Device Manufactured: 10/30/2012
• 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): Required Intervention
• Patient Age: 67 YR