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

Model Number 97714

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Bruise/Contusion (1754); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient was very thin and had lost 40 pounds, and the ins was so uncomfortable.The patient reported that they could feel every ridge and they bruised from it on their skin.The patient was calling to know if there were smaller ins batteries.The patient was redirected to their healthcare provider and manufacturer¿s representative to discuss the options.No further complications were reported.Additional information received from the consumer.It was reported that the patient had a lead and battery revision on (b)(6) 2018.They had lost a lot of weight and noted that the ins was implanted in a bad place and was sticking out; the healthcare provider didn't have a lot of choices of where to put it because they lost so much weight.The patient reported that since the revision it's been working out great- their new ins only took an hour to charge and everything was great and more comfortable.No further complications reported.

Manufacturer Narrative

Corrected information.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: 7717952
• MDR Text Key: 114956489
• Report Number: 3004209178-2018-16567
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Date Device Manufactured: 09/26/2016
• 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: 54 YR