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

Model Number 97702

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Cramp(s) (2193); Chest Tightness/Pressure (2463)

Event Date 03/03/2017

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.The patient reported that she met with a manufacturer¿s representative (rep) a week or so ago and she reprogrammed her stimulator and had given it enough time.The patient reported that she needed to reprogram it.The patient reported that instead of going down her left leg stimulation was so great around her ribcage.The patient reported that it was squeezing her ribcage and that happened only when she reclined.The patient reported that she wanted help to use the patient programmer to change stimulation so she could be more comfortable until she could meet with a rep again.The patient was initially on group a at 5.40 and the patient reported successfully changing to group b and increased to a comfortable setting.The patient reported that she felt stimulation in both legs.The issue resolved at the time of the report.No further complications anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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 she had terrible pain in the left leg that had gotten progressively worse over the weeks.Stimulation was on and patient increased stimulation from 7.60 to 8.20.The patient further mentioned that if stimulation was too high she felt binding feeling in chest.The patient subsequently reported that she was having cramping in the legs with waves of pain.The patient confirmed it was all the same pain that she was having previously.The patient changed from group b at 8.2 to group c and turned it up to 9.10 and could feel stimulation.The patient said she was still in pain and inquired which setting was for her left side.The patient was redirected to their healthcare provider.

Event Description

Additional information was received from the patient.It was reported that the patient's left leg was still very painful; there was excruciating pain.The chest problem had been resolved with lowering the number in the stimulator.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6450381
• MDR Text Key: 71485220
• Report Number: 3004209178-2017-06787
• Device Sequence Number: 1
• Product Code: GZB
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2017
• Date Device Manufactured: 12/14/2015
• 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: 77 YR
• Patient Weight: 98