MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97714

Device Problems No Device Output (1435); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Patient Device Interaction Problem (4001)

Patient Problems High Blood Pressure/ Hypertension (1908); Electric Shock (2554)

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 patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt turned ins off years ago because the system never worked right.The system would electrocute them all the time and it would bring their blood pressure all the way up and they could no longer control their blood pressure so they turned it off completely.The ins is in their butt and had not worked in years; pt tried to charge ins one time because they were told to but the ins never turned on one time and the ins had been off for 4 or 5 years.Pts health care provider (hcp) never done nothing to work with them on the ins.Pt use to go to the hcp every other week to get the ins reprogrammed for it use to electrocute them.Pt said they could deal with the pain rather than the electrocuting all the time for they would get a volt in their spine.Pt said they put it on quit or invisible and it would still electrocute them.Pt was put in the hospital because their blood pressure went to 300 and something over right at 200 and then was rushed to the hospital and put on morphine drip and after the third time of doing it they turned the ins off and they never had that problem since.Pt said they had blood pressure issues but they have never had their blood pressure at 3s or 2s.Pt said ins was turned off because their health was more important then supposedly pain relief.Pt said the ins would electrocute them if they moved or bent a certain way.Pt said the ins had not worked 3 out of the 6 years since implant, maybe longer.Pts ins wont even charge or come on.Pt wants the ins removed or have something done.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12530269
• MDR Text Key: 273330925
• Report Number: 3004209178-2021-14405
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Date Device Manufactured: 01/07/2015
• 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): Hospitalization