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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431)

Patient Problems Pain (1994); Tingling (2171); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.It was reported that the patient was programmed with adaptive stimulation (as) recently for upright, lying/left side, lying/right si de, and shortly after that the patient had so much tingling in their back, across the middle of the back on the right side when upright.The patient stated that there was a sore spot, they could hardly touch it, and it was throbbing.The patient noted taking a hys ingla/24 hour pain medication and may have to take a hydrocodone.The patient said they tried to turn the ins off but it was back on in 5 minutes.On the call the patient programmer showed that stimulation was on at 1.00v.The patient lowered the amplitude and sta ted it was better but still not comfortable.The patient then lowered to 0.00, which the patient stated was worse, so they increased and chose 0.50v, which the patient stated they will try because it was better.The patient confirmed that the as learned the new amplitude setting.No device issues were reported.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They reported they had not been sure how to turn down the voltage for the standing setting.They tried turning the voltage down but that did not work for them.They were scheduled for a reprogramming appointment for (b)(6) 2018.No further complications were reported or anticipated.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer.It was reported that a manufacturer's representative assisted them with programming their device; had to go 2 weeks.Patient reported the rep helped with continuous throbbing, however, they are still needing multiple pain meds are suggesting a pain pump.Additional information was received from the healthcare provider.It was reported that the program was not changed accidently.Hcp stated she returned it a week later and it was sorted out.It was reported now a 0.5v instead of 1.0v.It was reported that the tingling in back/ sore spot/ throbbing has decreased however still present.

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 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: 7575154
• MDR Text Key: 110287277
• Report Number: 3004209178-2018-12772
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 06/04/2018; 06/14/2018; 07/03/2018; 08/08/2018
• Supplement Dates FDA Received: 06/06/2018; 06/22/2018; 07/16/2018; 10/04/2018
• Date Device Manufactured: 04/06/2015
• 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 Age: 66 YR
• Patient Weight: 64