MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37713

Device Problems Energy Output To Patient Tissue Incorrect (1209); Positioning Problem (3009)

Patient Problems Bruise/Contusion (1754); Nerve Damage (1979); Therapeutic Effects, Unexpected (2099)

Event Date 03/12/2009

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 39565-30, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 37743, serial# (b)(4), implanted: (b)(6) 2009, product type: programmer, patient.Product id: 37752, serial# (b)(4), implanted: (b)(6) 2009, product type: recharger.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

A patient reported that following implantable neurostimulator (ins) replacement, the stimulator was not covering pain coming from toes.The patient stated that the manufacturer representative had not been able to program it to take care of the pain coming from toes.The stimulation was only going from the waist to the ankles.The patient stated there was not enough tissue to hold the implant in and so during surgery they had to do an "upside down pocket." it was also reported that the patient had the ins on but they could not feel stimulation due to low setting.The patient increased setting while on the phone and reported feeling stimulation.Patient later inquired if she should still feel residual stimulation after her stimulation is turned off.It was reviewed that it was possible to have some residual stimulation, but not necessarily for an extended period of time.It turned out the patient still had stimulation on, though the setting was at 0.0 amplitude.The patient could still feel stimulation.The patient was able to turn stimulation off and not feel stimulation.Patient also reported a bruised rib cage as a result of the replacement surgery.Additional information was received from the patient.The patient reported that the doctor nicked a nerve.

Manufacturer Narrative

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

• Brand Name: RESTORE ADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6325514
• MDR Text Key: 67238079
• Report Number: 3004209178-2017-03673
• Device Sequence Number: 1
• Product Code: LGW
• 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: 02/13/2017

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: 02/28/2010
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: 02/08/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 01/29/2009
• 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
• Patient Age: 56 YR