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

Model Number 97713

Device Problems Failure to Deliver Energy (1211); Material Frayed (1262); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)

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

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37761, serial#: (b)(4), product type recharger:, other relevant device(s) are: product id: 37761, serial/lot #: (b)(4), analysis of the recharger c0612743 found evidence of a frayed cord.Fdc code 4315 applies to the recharger.Fdc code 67 applies to the implantable neurostimulator.Fdm 10 and fdr 140 apply to the recharger.Fdm 4117 and fdr 3221 apply to the implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient with an implantable neurostimulator (ins), and it was reported that the recharger would not charge from the wall.The patient stated the desktop charger cord was frayed, and the connector pin loose.The patient noted the ins would not charge and the reposition antenna screen was seen.The patient had not been able to charge for a month so she took aspirin for her sciatic nerve pain, because she did not have therapy, since she could not charge.The patient had not been able to charge for weeks.The patient did not have a patient programmer.Patient was issued a new desktop charger and recharger and it was reviewed that she should follow up with her healthcare provider (hcp) if these did not resolve the issue.There were no reported complications and no further complications were expected.Patient was implanted for spinal pain.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 9468942
• MDR Text Key: 176997864
• Report Number: 3004209178-2019-23805
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• 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 Age: 72 YR