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

Model Number 97702

Device Problems Energy Output Problem (1431); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the patient¿s friend/family member regarding the patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient¿s device was at eos (end of service).It was reviewed that the device was off/disabled and no longer providing therapy.It was reviewed that the patient should contact their managing healthcare provider (hcp) to schedule a replacement surgery.It was indicated that the patient initially reported seeing the eri (elective replacement message) on their programmer and during the call they stated it changed to eos ((b)(6) 2018).There was no allegation/dissatisfaction with the ins longevity.It was reported that the patient had been uncomfortable and in a lot of pain.It was reported that their pain and discomfort began on (b)(6) 2018.Their device was at eri on (b)(6) 2018.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the ins had gone dead and the patient's pain level was at a 10 because the ins was out.The patient had a consultation for a replacement surgery but the doctor they met with told them the surgery could not be done at a surgery center, but rather would need to be done in a hospital because of the patient's pre-existing conditions including: congestive heart failure, chronic obstructive pulmonary disease (copd), a bladder issue, and of being older in age.It was noted that the caller did not allege that these pre-existing conditions were related to the device/therapy.Therefore, the caller has been having a hard time finding a doctor to perform the replacement surgery.Manufacturer representatives (reps) were contacted for assistance.A rep contacted the caller and provided them with names and numbers of two surgeons in their area.No further complications were reported or anticipated.

Manufacturer Narrative

Contains all applicable codes.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer on (b)(6) 2018 reporting that they could tell if the ins was working or not working.The patient had gone to the clinic but the hcp was not able to take care of them at the hospital setting.No further complications were reported.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• 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: 7561401
• MDR Text Key: 109950795
• Report Number: 3004209178-2018-12386
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 12/04/2013
• 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: 86 YR
• Patient Weight: 77