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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Nausea (1970); Pain (1994); Burning Sensation (2146); Weight Changes (2607); No Known Impact Or Consequence To Patient (2692); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 97714, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for spinal pain.It was reported the patient had a broken vertebrae, constipation, excruciating pain, and feels like ¿on fire¿.The patient was in a lot of pain.It was noted the patient was in a psych hospital now.The outcome of the event was unknown.Reference manufacturer report # 3004209178-2017-04392.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the healthcare provider (hcp) reported they were aware of the patient¿s symptoms but didn¿t think any of them were related to the manufacturer¿s device.According to the hcp the patient went on a hunting trip in (b)(6) 2016 and tripped and fell on a rock which caused all of the symptoms.The patient was last seen in the office in late (b)(6) and was asked to schedule x-rays and etc.The office had two appointments made for the patient to discuss and troubleshoot further but the patient cancelled them without any given reason.It was unknown what the patient¿s weight was at the time of the event, and the office hadn¿t heard anything from the patient lately as of (b)(6) 2017.No further complications were reported/anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient reported they were ¿in so much pain¿ at the time of follow-up.The patient reported they ¿had been very nauseous and had lost weight.¿ the patient noted he was previously on pain medications, his doctor took him off them, and that he may have been a bit addicted.The patient also noted they were bipolar and that he would ¿get a bit confused.¿ it was also noted the patient had been in two car accidents previously.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 6349619
• MDR Text Key: 68031973
• Report Number: 3004209178-2017-04393
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Date Device Manufactured: 04/11/2014
• 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): Other