MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SPECIFY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	39565-65
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.It was reported that the last surgery they had with their doctor the ins was taken out.Pt stated that health care provider (hcp) retired, so they had a different neurosurgeon now.Pt stated that they are having a cat scan done on friday as they were getting electrical current that went from the middle of their chest, under their breast, to their shoulder blade in their back and partly under their arm.Pt stated that the feeling comes and goes intermittently, however this morning it was there since before nine o'clock and it was getting pretty painful.Pt stated that the ins was removed on (b)(6) 2018.Pt stated that the lead was not removed as the lead was attached, so hcp didn't want to mess with the lead.Pt stated that they went to see dr.(b)(6) over a year ago and that hcp's pa said that since there was not an ins battery implanted they didn't know how to help them.Pt stated that they went to their primary care doctor for an ekg and x-rays and that everything looked fine and that hcp didn't know what could be causing the issue.Pt stated that they then went to see neurosurgeon, dr.(b)(6), however they weren't going to see hcp until after the cat scan results come back on friday; pt stated that they didn't know if they could wait that long.Pss advised the pt to seek medical attention as deemed necessary.Pt stated that they got a little nervous and were getting more nervous by the hour.Pss asked the pt if they knew where the lead was implanted; pt stated that a good estimation would be t3 or t4; pt stated that the ins was implanted in their right butt cheek.Pt stated that the ins worked really well for them and that they miss the ins.Pt's husband came on the phone and stated that they could see the lead way over to the left-hand side where it was disconnected on the x-rays.Caller stated that hcp gave them some options; caller stated that hcp was willing to put another implant in, so they could try to fix what was wrong with the present system that's implanted, or they could take the whole system out and potentially put in a new system at that same time.Caller asked depending on what hcp does or tries to do, would the pt have to pay the cost for a new implant; pss redirected the caller to hcp for further discussion.Additional information received.Patient reported hcp felt it was necessary in order to correct scoliosis left side.Had to pull and attach to rib to right side.Leads must have hindered it.Patient reported they have not used the stimulator since 2016.Patient reported extreme pain when they applied the charging disc to right buttocks.Belt caused pain in hips and stomach.Patient reported they don't know why the lead moved.Got pulsation in chest that pan under left breast, to armpit to left shoulder blade.Patient having a myelogram to see/located the runaway lead.Issue not yet resolved.2022-03-07 no new information.Please refer to 702012227 for the removal of the patient's ins.

• Brand Name: SPECIFY
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13723867
• Report Number: 3004209178-2022-03098
• Device Sequence Number: 20356137
• Product Code: LGW
• UDI-Device Identifier: 00613994560322
• UDI-Public: 00613994560322
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2015
• Device Model Number: 39565-65
• Device Catalogue Number: 39565-65
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/10/2022
• Date Device Manufactured: 10/26/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female