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

Model Number 37712

Device Problems Failure to Interrogate (1332); Use of Device Problem (1670); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for other pain indications ¿ other.It was reported the patient needed a replacement patient programmer (pp) because the pp was not working.It was stated the pp was ¿not working¿ because it took a long time to increase or decrease.Patient stated that she would ¿move it in several different areas to get it to connect¿, and she had to hold ¿it really tight against where the battery was¿.Prior the call, patient met with representative today at the pain clinic that did some in-person troubleshooting.It was noted the rep was checking the sync button on the pp and said the sync button ¿didn't work at all¿.It was confirmed the pp had not been wet, but she might have dropped it a time or two, and patient use (b)(6) batteries.It was noted the patient had the ins for 8 years.Patient services (pp) reviewed the expectation with getting a replacement pp and if getting a replacement pp didn't resolve the issue, patient would need to follow up with doctor in the near future.It was mentioned patient was told to get a replacement pp prior to visit doctor.It was stated the patient had ¿trouble with recharging the battery¿ too.It was noted her programmer stopped working and wouldn't connect to her stimulation, and the syn button did not work.No further complication and no symptoms were reported.On 2018-june-29; crts (b)(4) (con): additional information was received from patient.It was stated the patient ordered a new programmer and it helped some with the problems she was having with connecting to everything but then she went to a pain specialist because it wasn't back to what it should have been because her battery was over 8 years old and the doctor decided that he need to replace the battery which he did.Patient stated the reason for her call was to find out what she should do with her previous programmer that she no longer used.Patient services (pss) reviewed options for what to do with the older programmer since the repair team did not accept donations for the model programmer.Patient said she received this programmer from the repair team.Patient said the problem that led to the programmer and the implant being replaced were the same ones documented in previous call.Patient said her current device was working great and there were no allegations towards her current device.No further complication and no symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information from patient was received.It was stated the replacement of patient programmer (pp) did not resolve the patient had ¿trouble with recharging the battery, wouldn't connect to her stimulation, it took a long time to increase or decrease, and patient had to hold ¿it really tight against where the battery was¿.It was noted those issue hadn't been resolved, so patient had to have the battery replaced in her hip, it was 8 years old and it was working now.No further complication and no symptoms were reported.

Manufacturer Narrative

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

• Brand Name: RESTORE ULTRA
• 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: 7658795
• MDR Text Key: 113042387
• Report Number: 3004209178-2018-14890
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 05/14/2010
• 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