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

Model Number 97713

Device Problems Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  Injury  

Event Description

A coupling problem was reported for the past week or two, unable to get any coupling boxes.The patient felt the implantable neurostimulator (ins) in her ribs.The ins may be flipped, flip is not confirmed at this time.The antenna locate feature resulted in a range from 48-62, but coupling could still not be established.The company representative could feel the ins and the leads seemed to be coming from the left side.Telemetry was able to be established with the 8840 (clinician programmer).The patient was going to be sent back to the neurosurgeon who would likely order an x-ray.A couple days later it was confirmed that the ins is in the patient¿s left abdomen and flipped when she sits up and slouches.The patient has an appointment with her neurosurgeon to tack it down or move it so it won¿t flip.The patient was able to go home and manually flip it back and was able to fully charge until her appointment on 03/10/2015.Six days later it was reported that the patient is receiving effective therapy.The neurosurgeon will replace the extension to connect with patient¿s lead and put the ins in the back left flank.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_ext, serial# (b)(4), implanted: (b)(6) 1995, product type: extension; product id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 1995, product type: lead; product id 97754, serial# (b)(4), product type: recharger; product id 97740, serial# (b)(4), product type: programmer, patient; product id neu_unknown_lead, serial# unknown, product type: lead.(b)(4).

Event Description

The patient reported a month later that she had an appointment on (b)(6) 2015 with a company representative and her doctor.The patient received assistance from her doctor or company representative and her concerns were resolved.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the patient was going to be having an mri of her shoulder to look at disease progression and bursitis in the shoulder (she had a ct in the past as well as an mri).It was noted the patient had surgery on the shoulder but was still having problems with it and the hcp wanted another mri of the shoulder.It was reviewed that the patient was head eligible only and shouldn¿t have had the previous mri last october due to the original lead wire and new extension.In (b)(6) 2014, the patient noticed that the implantable neurostimulator (ins) was rotating and she was getting shocked in certain positions.In (b)(6) 2015 the patient met with the manufacturer¿s representative (rep) at the physician¿s office and noted issues with recharging and not getting coupling boxes filled in.On (b)(6) surgery was to take place but it was pushed to (b)(6).On (b)(6), the physician changed the patient¿s implant because in 2014 when she got her new implant, the physician put the device in the previous implant site and the pocket was too large.The implant was moved to the left buttocks.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4609022
• MDR Text Key: 5698267
• Report Number: 3004209178-2015-04825
• Device Sequence Number: 1
• Product Code: GZB
• 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,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

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: 12/14/2014
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2015
• Date Device Manufactured: 11/15/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00069 YR