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 Delayed Charge Time (2586); Battery Problem (2885)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Dizziness (2194); Distress (2329)

Event Date 12/15/2010

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 patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome.The patient reported that he was living in a nightmare because some days the numbing from the ins stayed in the spine and takes care of his pain but this morning he woke up in pain and couldn¿t find his patient programmer (pp) to adjust his stimulation.The pp is lost.The patient reported that he¿s been so stressed out looking all over for the pp that his head was spinning and he had a headache.The patient reported that due to his excessive pain he was having trouble remembering things.The patient reported that charging the implant has been a bad dream for him because sometimes he used high settings and that drained the implant battery quickly and since his implant is located on his butt and charging the implant can be a long experience and some days he just can¿t sit down the recharger that long.The patient reported that because of this its really been an effort for him to keep his implant charged up.No further complications were reported.

• 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: 8290649
• MDR Text Key: 134586083
• Report Number: 3004209178-2019-02082
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• Date Device Manufactured: 11/23/2010
• 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 Age: 62 YR