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

Model Number 37713

Device Problems Failure to Deliver Energy (1211); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 09/01/2014

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 implanted with an implantable neurostimulator (ins).It was reported that the ins was replaced on (b)(6) 2014.The reason for replacement was that it stopped working, ins died because the patient forgot to charge.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp) on 2018-jun-08.They are having a chief complaint about abrupt cessation of the spinal cord stimulation (scs).The manufacturer evaluated the generator and found that it was at end of life (eol).The patient had a battery replacement on 2014 (b)(6).The patient¿s preoperative diagnoses was chronic pain with their scs system generator eol.After informed consent was obtained, the patient was taken to the operating room where general anesthetic was administered by endotracheal tube by the anesthesia service while the patient was in a supine position on the operating table.Their previous skin incision was prepped and draped in the usual sterile fashion.This was located in the right lower quadrant.The skin incision was made with a 15- blade knife and then this was carried through the deeper tissues using bovie electrocautery on low power.The generator is encountered.The capsule was dissected free around this.There were 2 securing sutures.These were divided.Once the generator was dissected along with enough of the lead, it was slid out of position.The set screw was loosened.The lead was slid out of the generator.A new generator was brought up; slid into the pocket.The lead was slid into this generator and the torque set screwdriver used to tighten the set screw down.The system was then checked with the programmer.The system appeared intact.The hcp then used the 3-o prolene to suture the generator down and then 2-o vicryl inverted interrupted sutures to close the suture line.The skin was stapled.Dressed with neosporin ointment.Owens gauze, 4 x 4.The patient was undraped.Silk tape was used to complete the dressing.The patient was then taken to the recovery room after the procedure was terminated.No immediate complications were noted.Intravenous fluid was 600 ml.The patient did receive perioperative antibiotics.No further complications were reported/are anticipated.

• Brand Name: RESTORE ADVANCED
• 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: 7627194
• MDR Text Key: 111991962
• Report Number: 3004209178-2018-14056
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2009
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2018
• Date Device Manufactured: 02/27/2008
• 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): Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 61