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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Neck Pain (2433); Neck Stiffness (2434)

Event Date 09/21/2016

Event Type  malfunction  

Event Description

A consumer implanted for spinal pain reported since (b)(6) 2016 they had been experiencing a muscle pain/strain/stiffness sensation in their neck and head on the left side.The consumer tried turning stimulation down and off, but when they turned it off the pain got worse.It was noted the device was implanted to treat pain in the neck, shoulder, and leg due to "chiari malformation." the consumer already saw their physician last thursday and was going to be seeing them tomorrow as well.

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

The patient reported overstimulation in her head at night so she turns it off during the night; she noted that when she gets up in the morning she has headaches.The patient reported she tried decreasing the amplitude down to 0.2 and that was when the headaches and spasms in the neck area started.The patient reported a loss of therapeutic effect because her leg pain was getting worse.The pain was a 5 on a scale from 1 to 10.She reported she changed her pain medication and was given a med that wasn¿t as strong, which may be why she was noticing the pain more.The patient was to follow up with her healthcare professional.

Event Description

The patient reported overstimulation in her head at night so she turns it off during the night; she noted that when she gets up in the morning she has headaches.The patient reported she tried decreasing the amplitude down to 0.2 and that was when the headaches and spasms in the neck area started.The patient reported a loss of therapeutic effect because her leg pain was getting worse.The pain was a 5 on a scale from 1 to 10.She reported she changed her pain medication and was given a med that wasn¿t as strong, which may be why she was noticing the pain more.The patient was to follow up with her healthcare professional.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6040451
• MDR Text Key: 57875590
• Report Number: 3004209178-2016-22077
• Device Sequence Number: 1
• Product Code: GZB
• 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: 11/17/2016

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: 04/14/2017
• 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: 09/26/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 11/10/2016
• Supplement Dates FDA Received: 11/09/2016; 11/09/2016; 11/17/2016; 09/26/2017
• Date Device Manufactured: 05/24/2016
• 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: 43 YR