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

Model Number 97702

Device Problems Therapy Delivered to Incorrect Body Area (1508); Unexpected Therapeutic Results (1631); Human-Device Interface Problem (2949)

Patient Problems Fever (1858); Headache (1880); Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Malaise (2359)

Event Date 09/19/2018

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 non-malignant pain.It was reported that the person who programmed the patient's ins did a terrible job and the patient couldn't receive relief.They were sedated for 4 hours (during their implant surgery and they noted it shouldn't have lasted that long) and the person who performed the programming wasn't able to wake them up.The patient's programming for their evaluation worked out great; their trial was a "single line" and the results from the trial are why they went on to the permanent implant.At this point the patient was really sick and was on antibiotics.They had a headache since the ins was put in and were feeling a horrible pain at the incision site and mentioned that the ins should be covering that area.They were going to go to the general hospital because they were also vomiting and had a low grade fever.The patient was on fentanyl patches.The way the ins was set up there was nothing happening in their pelvic area at all, it was just down one leg and one of the settings was above their naval in the lumbar region.The patient was advised to fol low up with their healthcare provider for possible reprogramming.The patient had an appointment on monday.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer's representative.It was reported that the infection-like symptoms were resolved and the stimulation down their leg (and not being in the pelvic area) was resolved with a simple reprogramming post-op.The patient's stimulator was reprogrammed and they reported having good relief at their last appointment.No further complications 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: 7931410
• MDR Text Key: 122622597
• Report Number: 3004209178-2018-22173
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• Date Device Manufactured: 12/28/2017
• 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): Required Intervention
• Patient Age: 56 YR