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

Model Number 97714

Device Problems Battery Problem (2885); Charging Problem (2892)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/05/2016

Event Type  Injury  

Event Description

Information was received from a healthcare professional of a clinical study regarding a patient.Device interrogation and device data on (b)(6) 2016 determined the spinal cord stimulator battery was discharged.The therapy was suspended on (b)(6) 2016.A device diagnosis of the ins unable to recharge was reported.A clinical diagnosis was not applicable.The event was related to the device or therapy, not related to the implant procedure.A recharge session with the manufacturer had not occurred at the time as the patient was considering explant, however, the patient has recently requested a device replacement.Additional information from the healthcare professional of the clinical study reported that the ins was explanted/replaced on (b)(6) 2017.The event resolved without sequelae.

Manufacturer Narrative

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

Event Description

Additional information from the healthcare professional of the clinical study indicated that it was believed that the device was returned, however, there was no documentation of tracking information at the site.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6796917
• MDR Text Key: 82775438
• Report Number: 3004209178-2017-17529
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Date Device Manufactured: 08/27/2013
• 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
• Patient Age: 75 YR
• Patient Weight: 97