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

Model Number 37714

Device Problems Therapy Delivered to Incorrect Body Area (1508); Material Separation (1562); Unexpected Therapeutic Results (1631); Malposition of Device (2616); Environmental Compatibility Problem (2929); Positioning Problem (3009)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that a patient was having a revision done tomorrow.It was stated that the current lead was going to be moved, a second lead added, and the implantable neurostimulator (ins) might be moved.It was reported that the patient had loss of therapeutic effect.The patient reported that her trial was excellent, but that she has had issues with the device since it was implanted.It was stated that they think the lead may be in the wrong position.The caller said that she had foot surgery in (b)(6) 2013 and since then she can't stand to have stimulation on.The patient stated that her settings were meant for her "pre-op pain ," and that they tried changing stimulation to the highest frequency.Additional information received reported that the patient had stimulation in the wrong location.It was stated that the stimulation was not in the optimal location.It was stated that the pocket was in an uncomfortable position so a new pocket was created and the ins was repositioned and remained in use.It was reported that the original lead was removed and two new compact octad leads were placed for more optimal stimulation.It was noted that upon explant of the original lead and titan anchor, the anchor fell apart- the clear cover came off first followed by the metal internal components.It was reported that impedance testing, x-rays, and reprogramming had been performed.It was stated that the issue was resolved.Additional information received reported that all electrodes had been in normal range.It was stated that the x-ray showed that the leads looked posterior and midline, ¿just slightly low for pain pattern¿.It was reported that after reprogramming they could stimulate the lower extremities but the sensation was painful.It was noted that the anchor had been discarded after explant.It was reported that the patient was doing ¿great¿ post-op.It was stated that the battery position was more optimal and paresthesia from stimulation was comfortable and in the appropriate position.It was noted that the manufacturer¿s representative had not seen or heard from the patient since the day of surgery.

Manufacturer Narrative

Concomitant medical products: product id: 37746, serial# (b)(4), product type: programmer, patient.Product id: 3777-60, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.Product id: 37754, serial# (b)(4), product type: recharger.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97791, lot# n397414, implanted: (b)(6) 2014, product type: accessory.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 3550-39, product type: accessory.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

(b)(4).

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 3836493
• MDR Text Key: 4396687
• Report Number: 3004209178-2014-09747
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2014

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: 08/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 05/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2014
• Date Device Manufactured: 10/10/2012
• 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: 00035 YR