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

Model Number 97714

Device Problems Break (1069); Difficult to Remove (1528); Low Battery (2584); Device Or Device Fragments Location Unknown (2590); Device Displays Incorrect Message (2591); Impedance Problem (2950)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Injury (2348)

Event Date 07/13/2017

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

Information was received from a healthcare professional of a clinical study regarding a patient with an implantable neurostimulator (ins) for spinal pain and complex regional pain syndrome type i.It was reported that the patient has had good pain relief for their right leg pain and now was developing similar pain in the left leg, suboptimal pain relief in left leg.The ins was implanted in the right abdomen and was now at end of battery life.The existing system was not relieving pain on the left side.Reprogramming and recharging the system in the pain clinic did not improve pain relief.An impedance check revealed contact damage in leads, leads were fractured.The etiology indicated the relationship of the event to the device or therapy was possibly related, but not related to the implant procedure.The patient wished to have the system replaced with the new ins in a new left upper buttock pocket site.The entire system was explanted and replaced on (b)(6) 2017.The outcome was resolved without sequelae on (b)(6) 2017.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional.It was reported that the cause of the lead fractures were not determined.It was reported that the end of battery life was normal battery depletion.The patient's baseline weight was (b)(6) pounds.Additional information received from the healthcare professional noted that the surgeon cut the leads as they entered the right flank subcutaneous tract in route to the right abdominal ins.The extensions were quite far toward the abdominal pocket, and they were unable to remove from the spinal wound.

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: 6925605
• MDR Text Key: 88736751
• Report Number: 3004209178-2017-21269
• 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: health professional,study
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Date Device Manufactured: 05/13/2014
• 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: 41 YR
• Patient Weight: 88