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

Model Number 97714

Device Problem Charging Problem (2892)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Injury (2348)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient with an implantable neurostimulator (ins).It was reported that the patient was unable to sit for long enough to charge their ins secondary to a wound on their coccyx.The patient met with a manufacturer representative to have the battery charged on (b)(6) 2017.The ins was charged for several hours and it was noted that the patient would need to maintain the charge until their next reprogramming appointment, as the charge was weak.The etiology of the event was noted to be related to the recharge process, and the patient was unable to recharge due to being unable to sit.The event was considered to be resolved at that time.It was further reported that the patient presented for reprogramming on (b)(6) 2017 to determine if the device could be beneficial.The manufacturer representative was unable to charge the ins to reprogram it at that time.A generator replacement was recommended, and the patient elected to proceed with a device replacement with a different manufacturer.The entire system was explanted on (b)(6) 2017.The outcome of the event was noted as resolved without sequelae.No further complications were reported or anticipated.Indications for use are spinal pain and chronic lower back pain.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the event was related to subject non- compliance and that patient chose not to recharge.The device diagnosis was a difficulty charging the device.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

No new information was reported (the patient's weight was reported).

• 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: 7743369
• MDR Text Key: 115893292
• Report Number: 3004209178-2018-17266
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Date Device Manufactured: 04/30/2015
• 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: 76 YR
• Patient Weight: 116