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

Model Number 97714

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

Patient Problem Pain (1994)

Event Date 02/17/2020

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

Event Description

Information was received from a patient.It was reported that the connector pin broke off of the desktop charger as they were plugging it into the recharger.The patient stated that ¿everything was just dead¿ and initially stated that there was no green light on the desktop charger, but later confirmed that they could see the green light and that they thought there may be a short in their wall outlet.The patient clarified that the recharger was dead because they were not able to charge it due to the broken connector pin.The patient reported that they were in a lot of pain and that they weren¿t able to charge their implantable neurostimulator (ins) because the recharger was dead.It was noted that the issue occurred on the date of this report.The repair department was contacted and a replacement desktop charger was requested.No further complications were reported or anticipated.Indication for use is complex regional pain syndrome type i and spinal pain.

Manufacturer Narrative

Concomitant medical products: product id 37761, serial# (b)(4), product type recharger.Analysis of the desktop charger (c0484185) revealed that the connector pins were broken.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient responded via letter on 03-17 that their issue had resolved with the replacement part.No further complications were reported or anticipated.Indication for use is complex regional pain syndrome type i and spinal pain.

• 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
• MDR Report Key: 9760402
• MDR Text Key: 181654324
• Report Number: 3004209178-2020-04164
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 59