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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Unexpected Therapeutic Results (1631); Battery Problem (2885); Device Operates Differently Than Expected (2913)
Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330)
Event Date 12/08/2014
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 377775, lot# n0039784, implanted: (b)(6) 2005, product type: lead. Product id: 377775, lot# j0546559v, implanted: (b)(6) 2005, product type: lead. Product id: 97740, serial# (b)(4), product type: programmer, patient. Product id: 97754, serial# (b)(4), product type: recharger.
 
Event Description
On (b)(6) 2015, information was received from a consumer about a patient with an implantable neurostimulator (ins) for spinal pain. It was reported that there was implantable neurostimulator (ins) battery depletion. The patient indicated that their previous implant battery charge lasted a week, but their current device lasted two days. The patient was seeing the manufacturer representative (b)(6). The patient had been programmed twice since the most recent implant, but they had not been able to get pain relief to the top of their leg and the middle of the back. They couldn't get it to go up their back and couldn't get it on the right side of the legs and down through the straddle. Prior to the ins change, stimulation was fine for the patient. They could only increase or decrease stimulation with the current program. The event or symptoms occurred following the implant. The patient status was unknown. On (b)(6)2017, additional information was received from the patient reporting that they lost pain relief on their right side when their healthcare provider (hcp) replaced their ins. On (b)(6) 2017, additional information was received from the patient reporting that at first after the patient had their revision ((b)(6) 2014), they had soreness for about four to five months after (2015) and then the patient noticed their nerves were shot and their muscles were weak. The patient stated that they noticed the nerve damage and muscles weakness when they would lay in bed and then get up in the morning. It was reported that they didn't feel this all day. No further complications were reported/anticipated.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, 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 Key6632023
MDR Text Key101906549
Report Number3004209178-2017-12531
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2015
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/31/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2017 Patient Sequence Number: 1
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