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

Model Number 97714

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

Patient Problems Muscle Spasm(s) (1966); Complaint, Ill-Defined (2331)

Event Date 01/13/2016

Event Type  Injury  

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

A healthcare provider for a clinical study reported the patient was having quite a bit of difficulty with muscle spasms in between the 2 surgical sites resulting in an unscheduled clinic/office visit.When the event was reported to the study on (b)(6) 2016, tizanidine (4 mg qhs) was administered.On (b)(6) 2016, the patient reported the medication was not helpful so doterra deep blue was utilized.However, the patient continued to have muscle spasms as reported to the study on (b)(6) 2016 so trigger point injections were administered.The event was ongoing.It was noted the event was unlikely related to the device or therapy but was related to the implant procedure at the neurostimulator pocket site.Indication for use included non-malignant pain.

Event Description

The health care provider (hcp) additionally reported that the entire device system was explanted, and not replaced on (b)(6) 2016.The outcome was noted as unresolved at time of study exit/death/study closure.It was unclear which was meant and follow-up will be performed to clarify.

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

Information was received from a health care provider from a clinical study via a company representative (rep), that the patient¿s medical history included: back pain with leg pain, and radicular pain syndrome.The concomitant medications were: tramadol, trigger point injections (4cc 2% lidocaine, 4cc 0.5% marcaine, 40mg depo-medtrol, 60mg toradol), and tizanidine.It was noted that tizandine was also prescribed on (b)(6) 2016.

Manufacturer Narrative

The patient code has been added.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.

Manufacturer Narrative

Concomitant medical products: product id 977a260, lot# va122dn009, product type: lead.Product id 977a260, lot# va11eve037, product type: lead.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

Information was received from a healthcare professional of the clinical study regarding the implant and explant of the system.The implant procedure occurred on (b)(6) 2015.The lead entry level of the two leads was at t12-l1.The lead fixation method was unknown.The lead tip location was t7.No extensions were used.The leads were connected to the ins located in the left buttock.A system continuity check was completed using impedance testing and all impedances were within range.Per the physician, the therapy was not initiated at implant.Therapy was later initiated on (b)(6) 2016.The ins and leads were explanted on (b)(6) 2016 without replacement.The system was not replaced because it caused unacceptable complications.

Event Description

Additional information received from the healthcare professional of the clinical study reported the exact locations of the surgical sites with the muscle spasms included the mid lumbar and left buttock.No relationship between muscle spasm and therapy was identified.

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: 6230390
• MDR Text Key: 64086900
• Report Number: 3004209178-2017-00387
• Device Sequence Number: 1
• Product Code: GZB
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/06/2017

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: 10/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 03/03/2017
• Supplement Dates FDA Received: 01/13/2017; 02/14/2017; 02/17/2017; 02/17/2017; 03/06/2017; 09/28/2017
• Date Device Manufactured: 11/18/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR