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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Foreign Body Reaction (1868); Bone Fracture(s) (1870); High Blood Pressure/ Hypertension (1908); Pain (1994); Seizures (2063); Burning Sensation (2146); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 07/01/2017

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 an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient said their body was rejecting the stimulator.The patient stated that the stimulator is off.The patient said that it is ravishing their body with pain.The patient said they started to get constant sharp pain and horrible burning pain and that is how they know the stimulator is being rejected.The patient stated that the pain and burning is where the lead is implanted not the battery.The patient said they get burning in their body and their blood pressure was 189.The patient said they cannot put shoes on because they feet are in horrible pain beyond the normal.The patient said they did not have blood pressure medication.The patient was not eating or drinking because they were in too much pain.The patient stated that their high blood pressure dropped out and they went unconscious and broke bones.The patient does not know how long they were unconscious.The patient stated that they started having seizures.The next week they went flying and their right foot was turned out and they broke bones in their feet and both their knees.The patient also bashed their head.The patient mentioned going to the hospital following the falls.The patient stated that the device is making them very sick.No further complications were reported.No device allegations were made.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.The patient reported that for months her body had been rejecting the implant.The patient reported that it wasn¿t rejecting the batteries, it¿s the other part.The patient reported that she could not have an electrical stimulator (ins) because of seizures (mixed seizure disorder), no matter what area the ins was for, electricity goes to the brain causing more electricity.That patient reported that she voiced her concerns about this.The patient reported that she had some seizures when on.The patient reported that with the ins it¿s the whole body, longer in worse it gets, can¿t imagine what she was going through.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was reported that the patient no longer has their pain ins.The entire system was taken out because she had multiple complications after having it.The patient's body was rejecting the device.The patient also mentioned that their doctor knew that she can't have the device due to her medical issues, but still insisted for the patient to have one.No further information was reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the system was removed in (b)(6) 2018 (this was noted to be a discrepancy with patient records).The patient said that their issue had been resolved with the removal of the system.No further complications were reported.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7317284
• MDR Text Key: 101625176
• Report Number: 3004209178-2018-04516
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2019
• Date Device Manufactured: 02/09/2017
• 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; Required Intervention
• Patient Age: 63 YR