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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle Spasm(s) (1966)

Event Type  Injury  

Event Description

It was initially reported the patient was having muscle spasms when the stimulator turned on.It was noted the muscle spasms did not relieve once stimulation was off.It was logged the muscle spasms persisted for several days.It was reported the device was reprogrammed.It was logged that impedance testing, x-rays, and blood work were all done for diagnostic testing and troubleshooting.It was noted the issue was not resolved and the cause of the issue was not determined.It was further reported the patient was initially seen for reprogramming and to check impedances.It was noted the impedances were within normal limit.It was logged the patient was to turn the stimulator off for 2 weeks to allow for continued healing from surgery and to have blood work completed to rule out infection or heightened inflammatory response.It was noted that after 2 weeks, the patient turned the stimulator back on with the same result and the patient was requesting the stimulator be removed.It was reported the patient stated the cause of the spasms was from the stimulation turned on even when amplitude was below paresthesia threshold.It was reported that spasms "came on immediately" and stayed even after stimulator was shut off.It was noted nothing could be determined as to why this was happening.It was logged the stimulation was in the proper location and was not an uncomfortable sensation.It was reported the spasms subsided when the stimulator had been off for a few days.It was noted the patient was trying to get an appointment with another physician to have the device removed.It was further reported that the patient had the entire system removed on (b)(6) 2014.The devices were disposed of at the explant facility.

Manufacturer Narrative

Product id: 97740, serial# (b)(4), product type: programmer.Patient product id: 97754, serial# (b)(4), product type: recharger.Product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3674481
• MDR Text Key: 4238635
• Report Number: 3004209178-2014-04282
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• 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: 02/21/2014
• Initial Date FDA Received: 03/12/2014
• Date Device Manufactured: 11/01/2013
• 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 Outcome(s): Required Intervention