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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 Break (1069); High impedance (1291); Battery Problem (2885); Charging Problem (2892); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 97715, serial#: (b)(4), implanted: (b)(6) 2020, product type: implantable neurostimulator, product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead. Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead. Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 27-jun-2020, udi#: (b)(4), product id: 977a275, serial/lot #: (b)(4), ubd: 23-feb-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the implantable neurostimulator was replaced on 2020-dec-11 because the patient was charging his implantable neurostimulator too often.   his amplitude (voltage) on his implantable neurostimulator range from 8-9 volts and when using high frequency that depleted his battery rapidly. An impedance checked pre op, and electrodes 2/8/15 were greater than 40,000ohms. His main program was using electrodes 8/15. There were no factors noted to be contributing to this issue. When the implantable neurostimulator was replaced, the physician stated that the 0-7 lead was not seated properly in the old implantable neurostimulator. When he put the same lead into the new battery, after he screwed down, the lead pulled out. They were able to get it secured after inserting again and screwing down with the impedance high on 8/15. The patient was reprogrammed post-op with the out of range issues. Impedances were rechecked and 2/4/8/15 were all greater than 40,000 ohms. The manufacturer representative was able to reprogram to get adequate coverage and the patient has their follow-up post-op appointment on (b)(6) 2020.

 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11008074
MDR Text Key224416419
Report Number3004209178-2020-21860
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/14/2017
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/16/2016
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: 12/15/2020 Patient Sequence Number: 1
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