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

Model Number 97712

Device Problems Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/26/2019

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), device codes (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer about an implantable neurostimulator (ins) implanted for spinal pain.It was reported that the patient had a desktop charger connector pin broke.The patient stated that because she was not able to charge her insr over the weekend due to the broken dtc connector pin she wasn't able to charge her ins and she has not been able to get "relief".No medical or therapy problem was associated.No out of box failure was reported.No symptoms were reported.No further allegations/complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 37761, serial# (b)(4), product type: recharger.(b)(4).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: 9298999
• MDR Text Key: 176579073
• Report Number: 3004209178-2019-21402
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Date Device Manufactured: 10/16/2015
• 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 Age: 53 YR